Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

• ClinicalTrials.gov Identifier: NCT01383993
• Recruitment Status: Completed
• First Posted: June 28, 2011
• Results First Posted: May 9, 2014
• Last Update Posted: May 9, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Aspergillosis, Aspergilloma
• Intervention: Drug: Voriconazole
• Enrollment: 21

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Period Title: Overall Study
Started	15	4	2
Completed	12	3	1
Not Completed	3	1	1
Reason Not Completed
Adverse Event	1	1	0
Withdrawal by Subject	0	0	1
Marketed voriconazole in post-therapy	2	0	0

Baseline Characteristics

Arm/Group Title		Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg	Total
Arm/Group Description		Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Total of all reporting groups
Overall Number of Baseline Participants		15	4	2	21
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	15 participants	4 participants	2 participants	21 participants
		7.7 (2.8)	12.5 (0.6)	14.0 (0.0)	9.2 (3.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	15 participants	4 participants	2 participants	21 participants
	Female	9 60.0%	2 50.0%	1 50.0%	12 57.1%
	Male	6 40.0%	2 50.0%	1 50.0%	9 42.9%

Outcome Measures

1. Primary Outcome

Title	Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration
Description	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg*h/mL
	51.92; (51%)	83.39; (56%)	17.27; (28%)

2. Primary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Description	[Not Specified]
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
	7.753; (38%)	9.233; (55%)	3.092; (42%)

3. Primary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration
Description	[Not Specified]
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Median (Full Range); Unit of Measure: hrs
	2.96; (0.950 to 4.00)	4.00; (2.92 to 4.20)	1.34; (1.00 to 1.67)

4. Primary Outcome

Title	Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration
Description	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg*h/mL
	48.23; (83%)	59.42; (67%)	10.00 [1]; (NA%)

[1]

Number of analyzed participant was 1.

5. Primary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration
Description	[Not Specified]
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
	7.755; (50%)	7.910; (45%)	2.030 [1]; (NA%)

[1]

Number of analyzed participant was 1.

6. Primary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration
Description	[Not Specified]
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Median (Full Range); Unit of Measure: hrs
	1.09; (0.917 to 3.78)	1.00; (0.950 to 2.03)	1.00; (1.00 to 1.00)

7. Primary Outcome

Title	Number of Participants Assessed Near Distance Visual Acuity Test
Description	[Not Specified]
Time Frame	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit

Outcome Measure Data

Analysis Population Description

The safety analysis was performed on all subjects who received at least 1 dose of study medication.

Arm/Group Title	All Participants
Arm/Group Description:	Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	21
Measure Type: Number; Unit of Measure: participants
Screening	18
The 7th day of IV treatment	18
The 1st day of oral treatment	17
The 7th day of oral treatment	15
The 30 day follow up visit	14

8. Primary Outcome

Title	Number of Participants Assessed Color Vision Test
Description	[Not Specified]
Time Frame	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit

Outcome Measure Data

Analysis Population Description

The safety analysis was performed on all subjects who received at least 1 dose of study medication.

Arm/Group Title	All Participants
Arm/Group Description:	Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	21
Measure Type: Number; Unit of Measure: participants
Screening	19
The 7th day of IV treatment	18
The 1st day of oral treatment	17
The 7th day of oral treatment	15
The 30 day follow up visit	14

9. Primary Outcome

Title	Number of Participants Assessed Visual Questionnaire
Description	[Not Specified]
Time Frame	Screening, Day 7 (the 7th day of IV treatment), Day 8 (the 1st day of oral treatment), Day 14 (the 7th day of oral treatment), and the 30-day follow-up visit

Outcome Measure Data

Analysis Population Description

The safety analysis was performed on all subjects who received at least 1 dose of study medication.

Arm/Group Title	All Participants
Arm/Group Description:	Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	21
Measure Type: Number; Unit of Measure: participants
Screening	19
The 7th day of IV treatment	18
The 1st day of oral treatment	17
The 7th day of oral treatment	15
The 30 day follow up visit	14

10. Secondary Outcome

Title	Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration
Description	Ratio was calculated from the following formula; AUC12,ss Following Oral Administration over AUC12,ss Following IV Administration
Time Frame	AUC12, ss for IV:Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion. AUC12,ss for oral: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing.

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Mean (Standard Deviation); Unit of Measure: ratio
	1.077 (0.547)	0.648 (0.015)	0.476 [1] (NA)

[1]

Number of analyzed participant was 1.

11. Secondary Outcome

Title	Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Description	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg*h/mL
	66.50; (30%)	80.99; (41%)	40.00; (2%)

12. Secondary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Description	[Not Specified]
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
	6.381; (28%)	8.066; (34%)	3.835; (1%)

13. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Description	[Not Specified]
Time Frame	Day 7 (up to Day 20): predose, 1 hour after the start of infusion, 10-20 minutes after the end of infusion, and 4, 6, 8, and 12 hours after the start of infusion

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	4	2
Median (Full Range); Unit of Measure: hrs
	5.05; (2.87 to 11.8)	4.49; (1.00 to 11.1)	3.84; (1.67 to 6.00)

14. Secondary Outcome

Title	Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Description	AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: μg*h/mL
	79.86; (36%)	90.84; (19%)	34.40 [1]; (NA%)

[1]

Number of analyzed participant was 1.

15. Secondary Outcome

Title	Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Description	[Not Specified]
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: mcg/mL
	7.971; (31%)	8.912; (22%)	3.720 [1]; (NA%)

[1]

Number of analyzed participant was 1.

16. Secondary Outcome

Title	Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Description	[Not Specified]
Time Frame	Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

Outcome Measure Data

Analysis Population Description

The pharmacokinetic parameter analysis was performed on all treated participants who had at least 1 of the pharmacokinetic parameters of interest.

Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description:	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
Overall Number of Participants Analyzed	14	3	1
Median (Full Range); Unit of Measure: hrs
	2.07; (0.000 to 7.78)	2.03; (0.950 to 4.00)	3.80; (3.80 to 3.80)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
Arm/Group Description	Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).	Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
All-Cause Mortality
	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/15 (0.00%)	0/4 (0.00%)	0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Participants Aged 2 to <12 Years	Participants Aged 12 to<15 Years and Weighed <50 kg	Participants Aged 12 to<15 Years and Weighed ≥50 kg
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	13/15 (86.67%)	4/4 (100.00%)	1/2 (50.00%)
Blood and lymphatic system disorders
Febrile neutropenia † 1	10/15 (66.67%)	2/4 (50.00%)	1/2 (50.00%)
Histiocytosis haematophagic † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Congenital, familial and genetic disorders
Colour blindness † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Eye disorders
Chromatopsia † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Conjunctivitis † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Keratitis † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Photophobia † 1	5/15 (33.33%)	3/4 (75.00%)	1/2 (50.00%)
Vision blurred † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Gastrointestinal disorders
Abdominal pain † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Anorectal disorder † 1	0/15 (0.00%)	0/4 (0.00%)	1/2 (50.00%)
Diarrhoea † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Lip dry † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Painful defaecation † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Stomatitis † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Toothache † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Vomiting † 1	1/15 (6.67%)	1/4 (25.00%)	0/2 (0.00%)
General disorders
Catheter site pain † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Pyrexia † 1	1/15 (6.67%)	1/4 (25.00%)	0/2 (0.00%)
Hepatobiliary disorders
Hepatic function abnormal † 1	2/15 (13.33%)	1/4 (25.00%)	0/2 (0.00%)
Infections and infestations
Cystitis † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Pneumonia † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Sepsis † 1	1/15 (6.67%)	1/4 (25.00%)	0/2 (0.00%)
Injury, poisoning and procedural complications
Fall † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Tibia fracture † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Investigations
Alanine aminotransferase increased † 1	1/15 (6.67%)	2/4 (50.00%)	0/2 (0.00%)
Aspartate aminotransferase increased † 1	1/15 (6.67%)	2/4 (50.00%)	0/2 (0.00%)
Blood bilirubin increased † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Blood potassium decreased † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Blood pressure increased † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Blood urine present † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Gamma-glutamyltransferase increased † 1	1/15 (6.67%)	1/4 (25.00%)	0/2 (0.00%)
Liver function test abnormal † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Weight decreased † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Metabolism and nutrition disorders
Hypoalbuminaemia † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Back pain † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Pain in extremity † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Nervous system disorders
Headache † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Respiratory, thoracic and mediastinal disorders
Epistaxis † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Hypoxia † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Oropharyngeal pain † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Skin and subcutaneous tissue disorders
Dermatitis † 1	2/15 (13.33%)	0/4 (0.00%)	0/2 (0.00%)
Eczema † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
Pruritus † 1	1/15 (6.67%)	0/4 (0.00%)	0/2 (0.00%)
Rash † 1	3/15 (20.00%)	0/4 (0.00%)	1/2 (50.00%)
Vascular disorders
Hyperaemia † 1	0/15 (0.00%)	1/4 (25.00%)	0/2 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 16.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

• Name/Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.
• Phone: 1-800-718-1021
• EMail: ClinicalTrials.gov_Inquiries@pfizer.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mori M, Kobayashi R, Kato K, Maeda N, Fukushima K, Goto H, Inoue M, Muto C, Okayama A, Watanabe K, Liu P. Pharmacokinetics and safety of voriconazole intravenous-to-oral switch regimens in immunocompromised Japanese pediatric patients. Antimicrob Agents Chemother. 2015 Feb;59(2):1004-13. doi: 10.1128/AAC.04093-14. Epub 2014 Dec 1.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01383993
• Other Study ID Numbers: A1501096
• First Submitted: June 27, 2011
• First Posted: June 28, 2011
• Results First Submitted: April 7, 2014
• Results First Posted: May 9, 2014
• Last Update Posted: May 9, 2014