This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase 2/3 Study of IGSC, 20% in PIDD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01218438
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : February 15, 2017
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Primary Immunodeficiency Diseases (PID)
Interventions Biological: Immune Globulin Intravenous (Human), 10% Solution
Drug: Immune Globulin Subcutaneous (Human), 20% Solution
Enrollment 86
Recruitment Details Participants were enrolled (signed informed consent) at 15 sites.
Pre-assignment Details A total of 86 participants provided informed consent. 9 of these participants did not start Epoch1, of which there were 6 screen failures; 2 were not able to receive their first infusion according to protocol timeline; and 1 withdrew. Therefore, 77 participants started Epoch 1 of the study.
Arm/Group Title Study Participants
Hide Arm/Group Description - EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Period Title: Epoch 1
Started 77
Completed 74
Not Completed 3
Reason Not Completed
Physician Decision             2
Adverse Event             1
Period Title: Epoch 2
Started 45
Completed 45
Not Completed 0
Period Title: Epoch 3
Started 74
Completed 70
Not Completed 4
Reason Not Completed
Withdrawal by Subject             3
Adverse Event             1
Period Title: Epoch 4
Started 70
Completed 67
Not Completed 3
Reason Not Completed
Physician Decision             1
Withdrawal by Subject             2
Arm/Group Title Study Epochs 1-4
Hide Arm/Group Description - EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study. - EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Baseline Participants 77
Hide Baseline Analysis Population Description
Safety Analysis Dataset: All participants who received at least one dose of immunoglobulin.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 77 participants
36.0
(3 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 77 participants
Female
37
  48.1%
Male
40
  51.9%
1.Primary Outcome
Title Rate of Acute Serious Bacterial Infections Per Year (ASBI)
Hide Description Annual rate of validated acute serious bacterial infections was calculated using a Poisson model to account for the different lengths of observation per participant. The observation period for each participant starts with the day of the first subcutaneous (SC) infusion in Study Epoch 2 and ends with the day of the End of Study visit.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Study Participants
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: Estimated infections/ year
0.012
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Poisson
Estimated Value 0.012
Confidence Interval (1-Sided) 99%
0.024
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Annual Rate of All Infections Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated infections/year
3.86
(2.77 to 5.22)
2.41
(1.89 to 3.03)
3.Secondary Outcome
Title Annual Rate of Sinus Infections Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (99% Confidence Interval)
Unit of Measure: Estimated infections/year
0.97
(0.61 to 1.45)
0.69
(0.50 to 0.93)
4.Secondary Outcome
Title Annual Rate of Fever Episodes Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated episodes/year
0.61
(0.34 to 0.99)
0.13
(0.08 to 0.21)
5.Secondary Outcome
Title Annual Rate of Days Off School/Work or Days Unable to Perform Normal Daily Activities Due to Illness or Infection Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated days off/participant
3.20
(1.88 to 5.03)
1.16
(0.70 to 1.79)
6.Secondary Outcome
Title Annual Rate of Days on Antibiotics Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated days/particpant
63.20
(43.39 to 88.29)
57.59
(40.71 to 78.59)
7.Secondary Outcome
Title Annual Rate of Hospitalizations for Illness or Infection Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated hospitalizations/participant
0.05
(0.02 to 0.10)
0.02
(0.01 to 0.04)
8.Secondary Outcome
Title Annual Rate of Days of Hospitalizations for Illness or Infection Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated days/participant
0.20
(0.08 to 0.42)
0.11
(0.05 to 0.20)
9.Secondary Outcome
Title Annual Rate of Acute (Urgent or Unscheduled) Physician Visits, or Visits to the Emergency Room for Illness or Infection Per Participant
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% - Epoch 1 Subcutaneous 20% - Epochs 2 Thru 4
Hide Arm/Group Description:
- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
- EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. - EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. - EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Estimated visits/participant
1.73
(1.03 to 2.68)
0.86
(0.54 to 1.28)
10.Secondary Outcome
Title Bioavailability of IGSC, 20% as Measured by the Ratio of the Geometric Means of Immunoglobulin G (IgG) AUCSC (Epoch 4) to IgG AUCIV,0-τ (Standardized to 1 Week) (Epoch 1) Adjusted for Dose and Dosing Frequency (Participants ≥12 Years Old)
Hide Description IGSC, 20% = Immune Globulin Subcutaneous (Human), 20% Solution; AUCSC = area under the concentration-time curve following subcutaneous administration; AUCIV,0-τ = area under the concentration-time curve following intravenous administration over a dosing interval
Time Frame Epoch 1: 3 week IV administration interval: Week 10, 11, 12, 13. Epoch 1: 4 week IV interval: Week 9, 10, 11, 12, 13. Epoch 4 Subcutaneous administration weeks 17, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set with correctly administered IGIV 10% dose in Epoch 1
Arm/Group Title Study Epochs 1-4
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 49
Geometric Mean (90% Confidence Interval)
Unit of Measure: Ratio
1.0855
(1.0394 to 1.1336)
11.Secondary Outcome
Title Trough Levels of IgG (Total), and IgG Subclasses at the End of the Treatment Intervals
Hide Description [Not Specified]
Time Frame Epoch 1: 3 week IV interval- weeks 0, 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 0, 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title IV 10% 3 Weeks IV 10% 4 Weeks SC 20% 145% IV 1 Week SC 20% Adjusted 1 Week SC 20% Individualized 1 Week
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 50 27 66 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: g/L
Total IgG
11.58
(10.36 to 12.94)
10.19
(9.55 to 10.88)
14.77
(13.86 to 15.74)
14.20
(13.48 to 14.96)
14.74
(14.03 to 15.48)
IgG Subclass 1
6.23
(5.47 to 7.09)
5.45
(5.04 to 5.91)
8.06
(7.51 to 8.65)
7.83
(7.33 to 8.38)
7.41
(6.98 to 7.87)
IgG Subclass 2
3.92
(3.53 to 4.35)
3.30
(3.08 to 3.54)
4.83
(4.47 to 5.21)
4.95
(4.65 to 5.26)
4.94
(4.69 to 5.20)
IgG Subclass 3
0.352
(0.285 to 0.435)
0.405
(0.347 to 0.473)
0.516
(0.463 to 0.574)
0.514
(0.458 to 0.578)
0.514
(0.456 to 0.580)
IgG Subclass 4
0.239
(0.202 to 0.281)
0.186
(0.165 to 0.209)
0.309
(0.273 to 0.350)
0.304
(0.280 to 0.331)
0.311
(0.289 to 0.335)
12.Secondary Outcome
Title Trough Levels of Anti-Tetanus Antibody
Hide Description [Not Specified]
Time Frame Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 64
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Pre-Study Medication- Epoch 1 Week 1 (N= 64)
2.28
(1.84 to 2.82)
IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)
3.36
(2.44 to 4.63)
IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16)
2.66
(2.04 to 3.48)
IV 10% 3 Weeks - Epoch 1 Week 10 (N= 19)
2.55
(1.83 to 3.56)
IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16)
2.26
(1.52 to 3.37)
IV 10% 4 Weeks- Epoch 1 Week 5 (N= 46)
1.92
(1.44 to 2.56)
IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)
2.31
(1.79 to 2.96)
IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)
2.28
(1.84 to 2.81)
SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)
4.08
(3.12 to 5.33)
SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)
4.49
(3.32 to 6.08)
SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 55)
3.76
(3.21 to 4.40)
SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)
3.09
(2.64 to 3.62)
SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)
2.75
(2.39 to 3.17)
SC 20% individualized 1 Week Epoch 4 Week 9 (N=58)
3.15
(2.73 to 3.63)
SC 20% individualized 1 Week Epoch 4 Week 17(N=51)
3.17
(2.74 to 3.67)
SC 20% individualized 1 Week Epoch 4 Week 29(N=54)
1.74
(1.48 to 2.03)
SC 20% individualized 1 Week- End of Study (N= 53)
1.97
(1.66 to 2.32)
13.Secondary Outcome
Title Trough Levels of Anti-Haemophilus Influenza B Antibody
Hide Description [Not Specified]
Time Frame Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Overall Study Arm
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 65
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
Pre-Study Medication- Epoch 1 Week 1 (N= 65)
2.91
(2.55 to 3.34)
IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)
2.71
(2.07 to 3.56)
IV 10% 3 Weeks- Epoch 1 Week 7 (N= 16)
3.08
(2.36 to 4.01)
IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19)
2.42
(1.75 to 3.36)
IV 10% 3 Weeks- Epoch 1 Week 13 (N= 14)
2.47
(1.85 to 3.29)
IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45)
2.82
(2.30 to 3.46)
IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)
2.71
(2.23 to 3.30)
IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)
2.74
(2.20 to 3.42)
SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)
4.07
(3.44 to 4.83)
SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)
3.94
(3.30 to 4.71)
SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 56)
3.59
(3.12 to 4.14)
SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)
3.62
(3.10 to 4.22)
SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)
3.47
(3.06 to 3.94)
SC 20% individualized 1 Week Epoch 4 Week 9 (N=58)
4.35
(3.87 to 4.89)
SC 20% individualized 1 Week Epoch 4 Week 17(N=51)
4.76
(4.21 to 5.39)
SC 20% individualized 1 Week Epoch 4 Week 29(N=54)
4.06
(3.55 to 4.65)
SC 20% individualized 1 Week- End of Study (N= 52)
5.07
(4.48 to 5.73)
14.Secondary Outcome
Title Trough Levels of Anti-Hepatitis B Antibody
Hide Description [Not Specified]
Time Frame Epoch 1: 3 week IV interval- weeks 1, 4, 7, 10, 13. Epoch 1: 4 week IV interval- weeks 1, 5, 9, 13. Epochs 2 & 3: Subcutaneous (SC) weeks 5, 9. Epoch 4: SC weeks 1, 9, 17, 29, 40 (week dependent on time to establish "Adjusted Dose" in Epoch 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epochs 1-4
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Overall Number of Participants Analyzed 66
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Pre-Study Medication- Epoch 1 Week 1 (N= 66)
266.6
(232.3 to 305.9)
IV 10% 3 Weeks- Epoch 1 Week 4 (N= 15)
357.8
(312.2 to 410.1)
IV 10% 3 Weeks- Epoch 1 Week 7 (N= 17)
402.6
(333.4 to 486.0)
IV 10% 3 Weeks- Epoch 1 Week 10 (N= 19)
376.6
(315.7 to 449.3)
IV 10% 3 Weeks- Epoch 1 Week 13 (N= 16)
392.2
(310.4 to 495.6)
IV 10% 4 Weeks- Epoch 1 Week 5 (N= 45)
301.1
(266.2 to 340.5)
IV 10% 4 Weeks- Epoch 1 Week 9 (N= 44)
304.0
(271.0 to 341.0)
IV 10% 4 Weeks- Epoch 1 Week 13 (N= 43)
296.3
(266.0 to 330.2)
SC 20% 145% IV 1 Week- Epoch 2 Week 5 (N= 29)
463.7
(425.0 to 506.0)
SC 20% 145% IV 1 Week- Epoch 2 Week 9 (N= 27)
525.0
(478.1 to 576.5)
SC 20% adjusted 1 Week- Epoch 3 Week 5 (N= 57)
581.9
(533.4 to 634.9)
SC 20% adjusted 1 Week- Epoch 3 Week 9 (N= 58)
622.4
(579.8 to 668.1)
SC 20% adjusted 1 Week- Epoch 4 Week 1 (N= 62)
552.8
(509.7 to 599.6)
SC 20% individualized 1 Week Epoch 4 Week 9(N= 58)
434.4
(400.4 to 471.2)
SC 20% individualized 1 Week Epoch 4 Week 17(N=53)
444.5
(408.2 to 484.1)
SC 20% individualized 1 Week Epoch 4 Week 29(N=54)
389.2
(355.9 to 425.7)
SC 20% individualized 1 Week- End of Study (N=56)
403.1
(371.7 to 437.1)
15.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Area Under the Curve (AUC)
Hide Description The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week)
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: g*days/L
352.05
(319.74 to 387.63)
410.40
(381.24 to 441.79)
108.33
(97.60 to 120.24)
115.21
(109.23 to 121.52)
16.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Dose Per Weight-adjusted Area Under the Curve (AUC)
Hide Description The AUC between adjacent infusions will be calculated by the trapezoidal rule. Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: (g*days/L)/(g/kg)
606.99
(495.29 to 743.87)
796.30
(715.36 to 886.40)
472.50
(411.07 to 543.10)
536.05
(495.58 to 579.82)
17.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance for Immune Globulin Administered Subcutaneously (IGSC)
Hide Description Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0-τ). (F= bioavailability)
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time point
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/kg/days
1.65
(1.34 to 2.02)
1.26
(1.13 to 1.40)
2.12
(1.84 to 2.43)
1.87
(1.72 to 2.02)
18.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Maximum Concentration (Cmax)
Hide Description The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Week Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: g/L
27.09
(24.30 to 30.19)
24.85
(23.18 to 26.64)
17.31
(15.11 to 19.82)
19.31
(18.13 to 20.57)
19.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Time to Maximum Concentration (Tmax)
Hide Description The minimum time (Tmax) to reach the maximum concentration (Cmax)
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: hours (h)
6.94
(3.96 to 12.17)
5.84
(3.62 to 9.40)
54.19
(36.28 to 80.92)
78.68
(65.37 to 94.70)
20.Secondary Outcome
Title Pharmacokinetics Parameters for Immunoglobulin G (IgG): Minimum Concentration (Cmin)
Hide Description The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 38 18 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: g/L
12.03
(10.64 to 13.60)
10.37
(9.50 to 11.33)
13.85
(12.61 to 15.21)
14.00
(13.14 to 14.91)
21.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Area Under the Curve (AUC)
Hide Description The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week )
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg*days/L
80.79
(65.58 to 99.53)
123.05
(93.36 to 162.18)
29.51
(23.25 to 37.46)
30.64
(26.29 to 35.72)
22.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Dose Per Weight-adjusted Area Under the Curve (AUC)
Hide Description The AUC between adjacent infusions will be calculated by the trapezoidal rule . Linear interpolation/extrapolation will be used to calculate the AUC for exact duration of the infusion intervals (21 or 28 days for IV administration and 7 days for SC administration). To allow for comparisons between Epochs 1, 2 and 4, AUC 0-τ will be standardized for the infusion intervals (3 or 4 weeks vs. 1 week) adjusted for the dose per weight.
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: (mg*days/L)/(g/kg)
139.29
(110.89 to 174.97)
239.99
(181.92 to 316.61)
128.72
(96.65 to 171.42)
141.78
(121.75 to 165.12)
23.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Clearance (CL) for Immune Globulin Administered Intravenously (IGIV) and Apparent Clearance (CL/F) for Immune Globulin Administered Subcutaneously
Hide Description Clearance (CL) or apparent clearance (CL/F) for IV and SC administration, respectively, will be determined by the formula: CL or CL/F = (Dose (mg/kg)) / (AUC 0- τ). (F= bioavailability)
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20%, 145% of IGIV 10% Study Epoch 4: IGSC 20%, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: mL/kg/days
7.18
(5.72 to 9.02)
4.17
(3.16 to 5.50)
7.77
(5.83 to 10.35)
7.05
(6.06 to 8.21)
24.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Maximum Concentration (Cmax)
Hide Description The maximum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20%, 145% of IGIV 10% Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: mg/L
6.31
(5.25 to 7.59)
7.22
(5.75 to 9.05)
4.40
(3.45 to 5.62)
4.86
(4.16 to 5.68)
25.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Time to Maximum Concentration (Tmax)
Hide Description The minimum time (Tmax) to reach the maximum concentration (Cmax)
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 % Study Epoch 4: IGSC 20 %, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Hours (s)
3.11
(2.69 to 3.59)
3.71
(2.69 to 5.12)
70.67
(51.14 to 97.66)
66.87
(56.22 to 79.53)
26.Secondary Outcome
Title Pharmacokinetics Parameters for Haemophilus Influenza B Antibody: Minimum Concentration (Cmin)
Hide Description The minimum concentration (Cmax) following administration of study drug (either immune globulin administered intravenously (IGIV) or immune globulin administered subcutaneously (IGSC).
Time Frame Epoch 1: 3 week IV interval: Weeks 10-13. Epoch 1: 4 week IV interval: Weeks 9-13. Epoch 2: Subcutaneous (SC) weeks 9-10. Epoch 4: SC weeks 17-18
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - sub-groups with data at relevant time points
Arm/Group Title Study Epoch 1: IGIV 10% Every 3 Weeks Study Epoch 1: IGIV 10% Every 4 Weeks Study Epoch 2: IGSC 20%, 145% of IGIV 10% Study Epoch 4: IGSC 20%, Individualized Dose
Hide Arm/Group Description:
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
Overall Number of Participants Analyzed 16 37 18 59
Median (95% Confidence Interval)
Unit of Measure: mg/L
2.82
(2.20 to 3.61)
3.13
(2.31 to 4.26)
3.97
(3.14 to 5.01)
3.71
(3.15 to 4.37)
27.Secondary Outcome
Title Correction Factor to Determine the Individually Adapted Dose in Study 170904 Epoch 4 (Dose Adjustment Table)
Hide Description There is a high degree of variability in catabolism of immunoglobulin G (IgG) between individuals. To address this, trough levels immediately prior to the 9th weekly infusion in Epoch 3 were measured. The ratio of the measured trough levels on subcutaneous (SC) (Epoch 3) and intravenous (IV) administration (Epoch1) were compared to the expected trough level determined in Epoch 2. This was used to determine the Individually Adapted Dose to be used in Epoch 4. This was an interim study analysis.
Time Frame 29 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetics interim analysis set to determine the Individually Adapted Dose for Epoch 4
Arm/Group Title Correction Factor
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: Correction factor
Trough Level Ratio: 0.93 or more 1.16
Trough Level Ratio: 0.94 1.14
Trough Level Ratio: 0.95 to 0.96 1.12
Trough Level Ratio: 0.97 to 0.98 1.11
Trough Level Ratio: 0.99 to 1.01 1.10
Trough Level Ratio: 1.02 to 1.04 1.09
Trough Level Ratio: 1.05 to 1.08 1.08
Trough Level Ratio: 1.09 to 1.13 1.07
Trough Level Ratio: 1.14 to 1.19 1.06
Trough Level Ratio: 1.20 to 1.26 1.05
Trough Level Ratio: 1.27 to 1.33 1.04
Trough Level Ratio: 1.34 to 1.40 1.03
Trough Level Ratio: 1.41 to 1.47 1.02
Trough Level Ratio: 1.48 to 1.55 1.01
Trough Level Ratio: 1.56 to 1.63 1.00
28.Secondary Outcome
Title Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Participant
Hide Description Number of related SAEs and AEs divided by number of participants
Time Frame Up to 20 months per subject (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title INTRAVENOUS 10% SUBCUTANEOUS 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Adverse events per participant
Non-SAEs - Including infections 1.039 2.122
Non-SAEs - Excluding infections 1.039 2.122
SAEs - Including infections 0.013 0
SAEs - Excluding infections 0.013 0
29.Secondary Outcome
Title Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Deemed Related to the Investigational Product Per Infusion
Hide Description Number of related SAEs and AEs divided by number of subjects and divided by number of infusions
Time Frame Up to 20 months per subject (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title INTRAVENOUS 10% SUBCUTANEOUS 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including Infections 0.247 0.036
Non-SAEs -Excluding Infections 0.247 0.036
SAEs - Including Infections 0.003 0
SAEs -Excluding Infections 0.003 0
30.Secondary Outcome
Title Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Participant
Hide Description Number of all SAEs and AEs divided by number of participants
Time Frame Up to 20 months per subject (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title INTRAVENOUS 10% SUBCUTANEOUS 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Adverse events per participant
Non-SAEs - Including infections 3.325 9.014
Non-SAEs - Excluding infections 2.338 6.297
SAEs - Including infections 0.013 0.027
SAEs - Excluding infections 0.013 0.014
31.Secondary Outcome
Title Number of Serious (SAEs) and Non-serious Adverse Events (AEs) (Including and Excluding Infections) Regardless of Relationship to the Investigational Product Per Infusion
Hide Description Number of all SAEs and AEs divided by number of infusions
Time Frame Up to 20 months per subject (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title IGIV, 10% Subcutaneous, 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including infections 0.390 0.114
Non-SAEs - Excluding infections 0.296 0.079
SAEs - including infections 0.003 0.000
SAEs - Excluding infections 0.003 0.000
32.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Participant
Hide Description Number of AEs that begin during or within 72 hours of completion of infusion divided by number of participants
Time Frame Within 72 hours of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Adverse events per participant
Non-SAEs - Including infections 1.377 4.581
Non-SAEs - Excluding infections 1.260 3.703
SAEs - Including infections 0.013 0
SAEs - Excluding infections 0.013 0
33.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 72 Hours of Completion of Infusion Per Infusion
Hide Description Number of AEs that begin during or within 72 hours of completion of infusion divided by the number of infusions
Time Frame Within 72 hours of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including infections 0.327 0.078
Non-SAEs - Excluding infections 0.299 0.063
SAEs - Including infections 0.003 0
SAEs - Excluding infections 0.003 0
34.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Participant
Hide Description Number of AEs that begin during or within 24 hours of completion of infusion divided by number of participants
Time Frame Within 24 hours of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Adverse events per participant
Non-SAEs - Including infections 0.961 3.365
Non-SAEs - Excluding infections 0.948 3.027
SAEs - Including infections 0 0
SAEs - Excluding infections 0 0
35.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 24 Hours of Completion of Infusion Per Infusion
Hide Description Number of AEs that begin during or within 24 hours of completion of infusion divided by number of infusions
Time Frame Within 24 hours of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including infections 0.228 0.058
Non-SAEs - Excluding infections 0.225 0.052
SAEs - Including infections 0 0
SAEs - Excluding infections 0 0
36.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion Per Participant
Hide Description Number of AEs that begin during or within 1 hour of completion of infusion divided by number of participants
Time Frame Within 1 hour of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Adverse events per participant
Non-SAEs - Including infections 0.662 1.865
Non-SAEs - Excluding infections 0.662 1.797
SAEs - Including infections 0 0
SAEs - Excluding infections 0 0
37.Secondary Outcome
Title Number of Adverse Events (AEs) (Including and Excluding Infections) That Begin During or Within 1 Hour of Completion of Infusion
Hide Description Number of AEs that begin during or within 1 hour of completion of infusion divided by number of infusions
Time Frame Within 1 hour of completion of infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including infections 0.157 0.032
Non-SAEs - Excluding infections 0.157 0.031
SAEs - Including infections 0 0
SAEs - Excluding infections 0 0
38.Secondary Outcome
Title Causally Related and/or Temporally Associated Adverse Events (AEs) Per Infusion
Hide Description The total number of all AEs (including and excluding infections) that begin during infusion or within 72 hours of completion of an infusion ("temporally associated") plus the total number of AEs (including and excluding infections) starting more than 72 hours following the completion of an infusion determined by the investigator to be at least possibly related to the study drug("related"), divided by the total number of infusions
Time Frame Within 72 hours post infusion for Temporally Associated AEs; End of each Study Epoch (Epoch 1, Epoch 2, Epoch 3, and Epoch 4) for Causally Related AEs
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Adverse events per infusion
Non-SAEs - Including infections 0.336 0.079
Non-SAEs - Excluding infections 0.309 0.064
SAEs - Including infections 0.003 0
SAEs - Excluding infections 0.003 0
39.Secondary Outcome
Title Percentage of Infusions Associated With One or More Local Non-serious Adverse Events (Non-SAEs)
Hide Description The number of infusions associated with local non-SAEs divided by the total number of infusions.
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Percent of infusions
0.9 1.8
40.Secondary Outcome
Title Percentage of Participants Reporting One or More Local Non-serious Adverse Events (Non-SAEs)
Hide Description [Not Specified]
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Percent of participants
3.9 31.1
41.Secondary Outcome
Title Number of Infusions for Which the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Hide Description [Not Specified]
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Infusions
Infusion rate reduced 4 5
Infusion interrupted 5 2
Infusion stopped 0 1
42.Secondary Outcome
Title Percentage of Participants for Whom the Infusion Rate Was Reduced and/or the Infusion Was Interrupted or Stopped Due to Tolerability Concerns or AEs
Hide Description [Not Specified]
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Percent of participants
Infusion rate reduced 1.3 5.4
Infusion interrupted 6.5 1.4
Infusion stopped 0.0 1.4
43.Secondary Outcome
Title Percentage of Infusions Tolerated With Intravenous or Subcutaneous Administration
Hide Description An infusion will be deemed as tolerated unless one of the following occurs: 1. Any serious related AE(s) 2. Any non-serious local or systemic related AE(s) that prevent(s) completion of infusion 3. Any severe non-serious local or systemic related AE(s) that occur within 60 minutes of completion of the infusion
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Overall Number of Units Analyzed
Type of Units Analyzed: Infusions
324 4327
Measure Type: Number
Unit of Measure: Percent of infusions
100 100
44.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 72 2 3 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
61
  84.7%
1
  50.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 1
10
  13.9%
1
  50.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 3
1
   1.4%
0
   0.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
45.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 70 2 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
62
  88.6%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
5
   7.1%
2
 100.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
1
   1.4%
0
   0.0%
1
  50.0%
0 0
Maximum Post-Infusion Grade 3
2
   2.9%
0
   0.0%
1
  50.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
46.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 69 2 3 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
59
  85.5%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
9
  13.0%
2
 100.0%
2
  66.7%
0 0
Maximum Post-Infusion Grade 2
1
   1.4%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
47.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 41 3 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
38
  92.7%
1
  33.3%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
1
   2.4%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
2
   4.9%
1
  33.3%
1
 100.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
1
  33.3%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
48.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 37 3 0 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
35
  94.6%
2
  66.7%
0
0
   0.0%
0
Maximum Post-Infusion Grade 1
2
   5.4%
1
  33.3%
0
0
   0.0%
0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0
0
   0.0%
0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
1
 100.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
0
   0.0%
0
49.Secondary Outcome
Title Short Term Tolerance - Change in Systolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 34 1 0 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
32
  94.1%
0
   0.0%
0
0
   0.0%
0
Maximum Post-Infusion Grade 1
2
   5.9%
1
 100.0%
0
0
   0.0%
0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0
0
   0.0%
0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
1
 100.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
0
   0.0%
0
50.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Diastolic Blood Pressure
Diastolic Blood Pressure 141-150 mmHg
Diastolic Blood Pressure 151-155 mmHg
Diastolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 72 1 3 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
69
  95.8%
0
   0.0%
1
  33.3%
0
   0.0%
0
Maximum Post-Infusion Grade 1
2
   2.8%
0
   0.0%
2
  66.7%
0
   0.0%
0
Maximum Post-Infusion Grade 2
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
Maximum Post-Infusion Grade 3
1
   1.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
51.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Diastolic Blood Pressure
Diastolic Blood Pressure 141-150 mmHg
Diastolic Blood Pressure 151-155 mmHg
Diastolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 71 2 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
67
  94.4%
0
   0.0%
1
 100.0%
0 0
Maximum Post-Infusion Grade 1
3
   4.2%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
1
   1.4%
2
 100.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
52.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Diastolic Blood Pressure
Diastolic Blood Pressure 141-150 mmHg
Diastolic Blood Pressure 151-155 mmHg
Diastolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 71 3 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
69
  97.2%
1
  33.3%
0 0 0
Maximum Post-Infusion Grade 1
1
   1.4%
2
  66.7%
0 0 0
Maximum Post-Infusion Grade 2
1
   1.4%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
53.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 42 3 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
41
  97.6%
1
  33.3%
0 0 0
Maximum Post-Infusion Grade 1
0
   0.0%
1
  33.3%
0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
1
   2.4%
1
  33.3%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
54.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 39 1 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
37
  94.9%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
2
   5.1%
1
 100.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
1
 100.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
55.Secondary Outcome
Title Short Term Tolerance - Change in Diastolic Blood Pressure: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Systolic Blood Pressure
Systolic Blood Pressure 141-150 mmHg
Systolic Blood Pressure 151-155 mmHg
Systolic Blood Pressure >155 mmHg
ER visit or hospitalization for malignant hypertension
Overall Number of Participants Analyzed 35 0 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
35
 100.0%
0
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
0
   0.0%
0
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
1
 100.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
0
   0.0%
0 0
56.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 71 4 1 1 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
61
  85.9%
3
  75.0%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 1
8
  11.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 2
2
   2.8%
1
  25.0%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
1
 100.0%
1
 100.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
57.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 66 6 2 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
53
  80.3%
3
  50.0%
1
  50.0%
0 0
Maximum Post-Infusion Grade 1
9
  13.6%
2
  33.3%
0
   0.0%
0 0
Maximum Post-Infusion Grade 2
4
   6.1%
0
   0.0%
1
  50.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
1
  16.7%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
58.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 66 5 3 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
55
  83.3%
1
  20.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
9
  13.6%
2
  40.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 2
2
   3.0%
2
  40.0%
2
  66.7%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
59.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 43 2 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
40
  93.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 1
1
   2.3%
2
 100.0%
0 0 0
Maximum Post-Infusion Grade 2
2
   4.7%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
60.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 39 2 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
36
  92.3%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 1
2
   5.1%
2
 100.0%
0 0 0
Maximum Post-Infusion Grade 2
1
   2.6%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
61.Secondary Outcome
Title Short Term Tolerance - Change in Heart Rate (Pulse): Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Heart Rate (Pulse)
Heart Rate (Pulse): Either Bradycardia (50 - 54 beats per minute) OR Tachycardia (101 - 115 beats per minute)
Heart Rate (Pulse): Either Bradycardia (45 - 49 beats per minute) OR Tachycardia (116 - 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (< 45 beats per minute) OR Tachycardia (> 130 beats per minute)
Heart Rate (Pulse): Either Bradycardia (ER visit or hospitalization for arrhythmia) OR Tachycardia (ER visit or hospitalization for arrhythmia)
Overall Number of Participants Analyzed 33 3 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
32
  97.0%
2
  66.7%
0 0 0
Maximum Post-Infusion Grade 1
1
   3.0%
1
  33.3%
0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
62.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 39 35 3 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
32
  82.1%
5
  14.3%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
7
  17.9%
28
  80.0%
1
  33.3%
0 0
Maximum Post-Infusion Grade 2
0
   0.0%
2
   5.7%
2
  66.7%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
63.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 46 23 3 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
35
  76.1%
2
   8.7%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 1
11
  23.9%
19
  82.6%
1
  33.3%
0
   0.0%
0
Maximum Post-Infusion Grade 2
0
   0.0%
1
   4.3%
2
  66.7%
0
   0.0%
0
Maximum Post-Infusion Grade 3
0
   0.0%
1
   4.3%
0
   0.0%
2
 100.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
64.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 38 32 2 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
32
  84.2%
4
  12.5%
0
   0.0%
0
   0.0%
0
Maximum Post-Infusion Grade 1
6
  15.8%
26
  81.3%
2
 100.0%
0
   0.0%
0
Maximum Post-Infusion Grade 2
0
   0.0%
2
   6.3%
0
   0.0%
1
  50.0%
0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
65.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 27 18 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
18
  66.7%
1
   5.6%
0 0 0
Maximum Post-Infusion Grade 1
9
  33.3%
17
  94.4%
0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
66.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 22 19 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
18
  81.8%
1
   5.3%
0 0 0
Maximum Post-Infusion Grade 1
4
  18.2%
18
  94.7%
0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0 0 0
67.Secondary Outcome
Title Short Term Tolerance - Change in Respiratory Rate: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Respiratory Rate
Respiratory Rate: 17 - 20 breaths per minute
Respiratory Rate: 21 - 25 breaths per minute
Respiratory Rate: > 25 breaths per minute
Intubation
Overall Number of Participants Analyzed 18 17 1 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
13
  72.2%
6
  35.3%
0
   0.0%
0 0
Maximum Post-Infusion Grade 1
5
  27.8%
11
  64.7%
1
 100.0%
0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
0 0
68.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 77 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
77
 100.0%
0 0 0 0
Maximum Post-Infusion Grade 1
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
69.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 74 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
73
  98.6%
0 0 0 0
Maximum Post-Infusion Grade 1
1
   1.4%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
70.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Intravenously (Human), 10% (IV 10%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered intravenously (Human), 10% (IV 10%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 74 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
72
  97.3%
0 0 0 0
Maximum Post-Infusion Grade 1
2
   2.7%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
71.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 1
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 45 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
45
 100.0%
0 0 0 0
Maximum Post-Infusion Grade 1
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
72.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 2
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 41 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
41
 100.0%
0 0 0 0
Maximum Post-Infusion Grade 1
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
73.Secondary Outcome
Title Short Term Tolerance - Change in Body Temperature: Immune Globulin Administered Subcutaneously (Human), 20% (SC 20%), Infusion 3
Hide Description Vital signs measured pre-infusion, during infusion, and post-infusion of Immune globulin administered subcutaneously (Human), 20% (SC 20%) was graded by the investigator and the sponsor using a 4-grade scale: mild (grade 1), moderate (grade 2), severe (grade 3) or life-threatening (grade 4) according to the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research; Guidance for Industry - Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September2007. *Note 5th Grade (grade 0) added to scale to reflect within normal range.
Time Frame Within 30 minutes pre-infusion, during infusion and within 30 minutes post infusion
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Pre-Infusion Toxicity Grade 0 Pre-Infusion Toxicity Grade 1 Pre-Infusion Toxicity Grade 2 Pre-Infusion Toxicity Grade 3 Pre-Infusion Toxicity Grade 4
Hide Arm/Group Description:
Normal Body temperature
Body Temperature, Fever (°C) of: 38.0 - 38.4
Body Temperature, Fever (°C) of: 38.5 - 38.9
Body Temperature, Fever (°C) of: 39.0 - 40
Body Temperature, Fever (°C) of: > 40
Overall Number of Participants Analyzed 36 0 0 0 0
Measure Type: Count of Participants
Unit of Measure: Participants
Maximum Post-Infusion Grade 0
36
 100.0%
0 0 0 0
Maximum Post-Infusion Grade 1
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 2
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 3
0
   0.0%
0 0 0 0
Maximum Post-Infusion Grade 4
0
   0.0%
0 0 0 0
74.Secondary Outcome
Title Number of Participants With Laboratory Confirmed Hemolysis That Occurred Following Investigational Product Administration
Hide Description Laboratory tests for confirmation of potential hemolysis include Coomb's test, haptoglobin, free hemoglobin, reticulocyte count, lactate dehydrogenase (LDH), and urine hemosiderin.
Time Frame Epoch 1: 3 week IV interval- weeks 0, 10. Epoch 1: 4 week IV interval- weeks 0, 9. Epoch 3: Subcutaneous (SC) week 9. Epoch 4: SC weeks 17, 18, 40
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Intravenous 10% Subcutaneous 20%
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 77 74
Measure Type: Number
Unit of Measure: Participants
0 0
75.Secondary Outcome
Title Quality of Life- Pediatric Quality of Life Inventory^TM (PEDS-QL^TM) (Observer: Parent) for the Age Group 2 to 7 Years
Hide Description The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set (subset of participants aged 2 to 7 years)
Arm/Group Title Start of Study Epoch 1 End of Study Epoch 1 End of Study Epoch 3 End of Study Epoch 4 Change End Epoch 1 to End Epoch 3 Change End Epoch 1 to End Epoch 4
Hide Arm/Group Description:
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Overall Number of Participants Analyzed 6 6 6 6 6 6
Median (95% Confidence Interval)
Unit of Measure: Score on a scale
Physical Functioning
95.31
(68.75 to 100.00)
93.75
(56.25 to 100.00)
96.88
(62.50 to 100.00)
92.19
(75.00 to 100.00)
1.56
(-3.13 to 9.38)
1.56
(-12.50 to 18.75)
Emotional Functioning
95.00
(70.00 to 95.00)
85.00
(50.00 to 95.00)
82.50
(60.00 to 100.00)
77.50
(55.00 to 85.00)
0.00
(-5.00 to 10.00)
-2.50
(-20.00 to 10.00)
Social Functioning
95.00
(65.00 to 100.00)
95.00
(25.00 to 100.00)
97.50
(25.00 to 100.00)
87.50
(50.00 to 100.00)
0.00
(-5.00 to 10.00)
0.00
(-15.00 to 25.00)
School Functioning
85.00
(55.00 to 100.00)
75.00
(30.00 to 83.33)
81.67
(40.00 to 100.00)
67.50
(25.00 to 91.67)
7.50
(0.00 to 25.00)
-5.00
(-10.00 to 8.33)
Psychosocial Health Summary
91.67
(65.00 to 98.08)
83.33
(38.33 to 92.31)
84.17
(41.67 to 100.00)
77.50
(46.67 to 90.38)
2.50
(0.00 to 11.67)
-3.33
(-8.33 to 8.33)
Physical Health Summary
95.31
(68.75 to 100.00)
93.75
(56.25 to 100.00)
96.88
(62.50 to 100.00)
92.19
(75.00 to 100.00)
1.56
(-3.13 to 9.38)
1.56
(-12.50 to 18.75)
Total Score
92.93
(69.57 to 98.81)
86.96
(59.78 to 94.05)
88.04
(60.87 to 100.00)
82.61
(60.87 to 94.05)
1.63
(0.00 to 10.87)
0.00
(-5.43 to 4.35)
76.Secondary Outcome
Title Quality of Life- PEDS-QL^TM (Observer: Participant) for the Age Group 8 to 13 Years of Age
Hide Description The Peds-QL is a generic Health-Related Quality of Life (HR QoL) instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. Higher scores indicate better quality of life (QoL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored. 2 summary scores (Psychosocial Health Summary, and Physical Health Summary) are presented, along with a total score.
Time Frame Up to 20 months (throughout entire study)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set participants aged 8 to 13 with scores at each respective time point.
Arm/Group Title Start of Epoch 1 End of Epoch 1 End of Epoch 3 End of Epoch 4 Change End of Epoch 1 to End of Epoch 3 Change End of Epoch 1 to End of Epoch 4
Hide Arm/Group Description:
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
Overall Number of Participants Analyzed 14 15 15 14 15 14
Median (95% Confidence Interval)
Unit of Measure: Score on a scale
Physical Functioning
89.06
(81.25 to 100.00)
90.63
(78.13 to 100.00)
87.50
(75.00 to 100.00)
93.75
(71.88 to 100.00)
0.00
(-3.13 to 9.38)
6.25
(0.00 to 15.63)
Emotional Functioning
87.50
(75.00 to 100.00)
80.00
(70.00 to 90.00)
80.00
(70.00 to 95.00)
87.50
(65.00 to 95.00)
0.00
(-5.00 to 5.00)
10.00
(-5.00 to 15.00)
Social Functioning
87.50
(80.00 to 100.00)
95.00
(80.00 to 100.00)
95.00
(85.00 to 100.00)
95.00
(85.00 to 100.00)
0.00
(0.00 to 5.00)
0.00
(0.00 to 5.00)
School Functioning
75.00
(55.00 to 90.00)
80.00
(60.00 to 85.00)
75.00
(55.00 to 85.00)
70.00
(55.00 to 85.00)
0.00
(-10.00 to 10.00)
-2.50
(-15.00 to 10.00)
Psychosocial Health Summary
80.83
(76.67 to 91.67)
83.33
(71.67 to 91.67)
81.67
(75.00 to 93.33)
81.67
(78.33 to 91.67)
0.00
(-3.33 to 8