Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
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| ClinicalTrials.gov Identifier: NCT02783482 |
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Recruitment Status :
Completed
First Posted : May 26, 2016
Results First Posted : October 28, 2022
Last Update Posted : December 9, 2022
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Sponsor:
Green Cross Corporation
Collaborators:
Parexel
Atlantic Research Group
Information provided by (Responsible Party):
GC Biopharma Corp ( Green Cross Corporation )
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Brief Summary:
The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immunologic Deficiency Syndromes | Biological: GC5107 | Phase 3 |
This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in subjects with Primary Humoral Immunodeficiency disease (PHID).
Subjects received intravenous infusions of the investigational product at the same dose and interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy. GC5107 was administered every 21 or 28 days for a period of 12 months.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency |
| Actual Study Start Date : | October 2016 |
| Actual Primary Completion Date : | July 2019 |
| Actual Study Completion Date : | July 2019 |
Resource links provided by the National Library of Medicine
Drug Information
available for:
Globulin, Immune
| Arm | Intervention/treatment |
|---|---|
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Experimental: GC5107
GC5107 Immune globulin intravenous (human) solution, 10% liquid
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Biological: GC5107
GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Other Names:
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Primary Outcome Measures :
- The Incidence of Acute Serious Bacterial Infections (SBI) [ Time Frame: One year ]
The incidence of acute serious bacterial infections (aSBIs) meeting FDA guidance criteria, which includes bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscesses, and osteomyelitis/septic arthritis.
Efficacy data is evaluated by comparing the frequency of acute serious bacterial infections per subject per year according to the FDA guideline of an upper one-sided 99% confidence limit < 1.0 per subject per year.
- The Proportion of Infusions With Temporally Associated Adverse Events (TAAEs) That Occur Within 72 Hours Following an Infusion of Test Product [ Time Frame: Within 72 hours after an infusion of GC5107 ]The proportion of infusions with temporally associated adverse events occurring during or within 72 hours following infusion, whether or not they were thought to be related to GC5107
Secondary Outcome Measures :
- The Incidence of Infections Other Than Acute Serious Bacterial Infections [ Time Frame: One year ]
- The Number of Days Missed From Work/School/Kindergarten/Daycare, or Days Unable to Perform Normal Daily Activities Due to Infections [ Time Frame: One year ]Based on the total number of days missed from work/school/kindergarten/daycare or days unable to perform normal daily activities due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
- The Number of Days of Unscheduled Physician Visits Due to Infections [ Time Frame: One year ]Based on the total number of days of unscheduled physician visits due to infections for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
- The Number of Days of Hospitalizations Due to Infections [ Time Frame: One year ]Subject with no experience of specific event will be included in the analysis as zero incidence, zero day, or zero time duration. The mean and SD will be calculated weighting for the duration of data available for each subject.
- The Number of Days of Intravenous (IV) Therapeutic Antibiotics [ Time Frame: One year ]Based on the total number of days of IV therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit -first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
- The Number of Days of Oral Therapeutic Antibiotics [ Time Frame: One year ]Based on the total number of days of oral (PO) therapeutic antibiotics for each subject. Mean and SD are calculated based on weighting for the duration of data available for each subject, where duration is defined as (date of last visit - first infusion date + 1) for subjects who complete the study; and defined as (date of withdrawal - first infusion date + 1) for subjects who withdraw from the study.
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| Ages Eligible for Study: | 2 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
- Male or Female, ages 2 to 70 years
- The subject has received 300-900 mg/kg of a licensed IGIV therapy at 21 or 28 day intervals for at least 3 months prior to this study
- At least 2 documented IgG trough levels of ≥ 500 mg/dL are obtained at two infusion cycles (21 or 28 days) within 12 months prior to study enrollment
Exclusion Criteria:
- Subject has secondary immunodeficiency
- Subject was newly diagnosed with PHID and has not yet been treated with immunoglobulin
- Subject has been diagnosed with dysgammaglobulinemia or isolated IgG subclass deficiency or isolated IgA deficiency with known anti-IgA antibodies
- History of severe reaction or hypersensitivity to IGIV or other injectable form of IgG
- Subject has a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction
- Subject has received blood products other than human albumin or human immunoglobulin within 12 months prior to enrollment
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02783482
Locations
Show 20 study locations
Sponsors and Collaborators
Green Cross Corporation
Parexel
Atlantic Research Group
Study Documents (Full-Text)
Documents provided by GC Biopharma Corp ( Green Cross Corporation ):
Documents provided by GC Biopharma Corp ( Green Cross Corporation ):
Study Protocol [PDF] January 4, 2019
Statistical Analysis Plan [PDF] November 5, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Green Cross Corporation |
| ClinicalTrials.gov Identifier: | NCT02783482 |
| Other Study ID Numbers: |
GC5107B_P3 |
| First Posted: | May 26, 2016 Key Record Dates |
| Results First Posted: | October 28, 2022 |
| Last Update Posted: | December 9, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes Immune System Diseases Immunoglobulins gamma-Globulins |
Immunoglobulins, Intravenous Rho(D) Immune Globulin Immunologic Factors Physiological Effects of Drugs |