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CompletedNCT01383993Updated May 9, 2014Results posted

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

A Phase 2 interventional study of Voriconazole and Voriconazole in Aspergillosis, Aspergilloma, sponsored by Pfizer. Completed at 6 sites in Japan. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2014-05-09.

Sponsored by Pfizer · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Non-randomized
Ages
2 Years to 15 Years
Sex
All
01

Study summary

In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

02

Conditions studied

  • Aspergillosis, Aspergilloma

Keywords

  • Open-Label
  • Pharmacokinetics
  • Intravenous to oral switch
  • Safety
  • Voriconazole
  • Immunocompromise
  • Children
  • High Risk For Systemic Fungal Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 21 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female from 2 to \<15 years of age.
  • Require treatment for the prevention of systemic fungal infection.
  • Expected to develop neutropenia (ANC \<500 cells/uL) lasting more than 10 days following chemotherapy.
  • Anticipated to live for more than 3 months.

Exclusion criteria

Exclusion Criteria:

  • Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
  • Documented bacterial or viral infection not responding to appropriate treatment.
  • Hypersensitivity to or severe intolerance of azole antifungal agents.
  • Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    1.0

    Immunocompromised children aged 2 to \<15 and 12 to \<15 years weighing \<50 kg who are at high risk for systemic fungal infection.

    Drug: Voriconazole

  • Experimental
    2.0

    Immunocompromised children aged 12 to \<15 years weighing more than 50 kg who are at high risk for systemic fungal infection.

    Drug: Voriconazole

Interventions

  • DrugVoriconazole

    Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h. Notes: If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)

    Also known as: UK-109,496; Vfend; Voriconazole

  • DrugVoriconazole

    Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h. Notes: If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)

    Also known as: UK-109,496; Vfend; Voriconazole

06

What researchers measure

Primary outcomes

  1. Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration

    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

  2. Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

    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

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration

    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

  4. Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration

    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

  5. Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration

    Time frame: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration

    Time frame: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

  7. Number of Participants Assessed Near Distance Visual Acuity Test

    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

  8. Number of Participants Assessed Color Vision Test

    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

  9. Number of Participants Assessed Visual Questionnaire

    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

Secondary outcomes

  1. Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration

    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.

  2. 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

    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

  3. Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

    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

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration

    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

  5. 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

    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

  6. Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

    Time frame: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

  7. Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

    Time frame: Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing

07

Results

Posted May 9, 2014

Participant flow

Participant flow — Overall Study
MilestoneParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Started1542
Completed1231
Not completed311
Withdrew: Adverse event110
Withdrew: Withdrawal by subject001
Withdrew: Marketed voriconazole in post-therapy200

Outcome measures

PrimaryArea Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration

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
Reported as:
Geometric mean · μg*h/mL
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration
μg*h/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following IV Administration51.92 ± 5183.39 ± 5617.27 ± 28
PrimaryMaximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
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
Reported as:
Geometric mean · mcg/mL
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
mcg/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following IV Administration7.753 ± 389.233 ± 553.092 ± 42
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration
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
Reported as:
Median · hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration
hrsParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following IV Administration2.96 (0.950 to 4.00)4.00 (2.92 to 4.20)1.34 (1.00 to 1.67)
PrimaryArea Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration

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
Reported as:
Geometric mean · μg*h/mL
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration
μg*h/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Area Under the Plasma Concentration-time Profile From Time Zero to Twelve Hours at Steady-State (AUC12,ss) Following Oral Administration48.23 ± 8359.42 ± 6710.00 ± NA
PrimaryMaximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration
Time frame:
Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Reported as:
Geometric mean · mcg/mL
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration
mcg/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) Following Oral Administration7.755 ± 507.910 ± 452.030 ± NA
PrimaryTime to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration
Time frame:
Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Reported as:
Median · hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration
hrsParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Time to Reach Maximum Observed Plasma Concentration (Tmax) Following Oral Administration1.09 (0.917 to 3.78)1.00 (0.950 to 2.03)1.00 (1.00 to 1.00)
PrimaryNumber of Participants Assessed Near Distance Visual Acuity Test
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
Reported as:
Number · participants
Number of Participants Assessed Near Distance Visual Acuity Test
participantsAll Participants
Screening18
The 7th day of IV treatment18
The 1st day of oral treatment17
The 7th day of oral treatment15
The 30 day follow up visit14
PrimaryNumber of Participants Assessed Color Vision Test
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
Reported as:
Number · participants
Number of Participants Assessed Color Vision Test
participantsAll Participants
Screening19
The 7th day of IV treatment18
The 1st day of oral treatment17
The 7th day of oral treatment15
The 30 day follow up visit14
PrimaryNumber of Participants Assessed Visual Questionnaire
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
Reported as:
Number · participants
Number of Participants Assessed Visual Questionnaire
participantsAll Participants
Screening19
The 7th day of IV treatment18
The 1st day of oral treatment17
The 7th day of oral treatment15
The 30 day follow up visit14
SecondaryRatio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration

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.
Reported as:
Mean · ratio
Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration
ratioParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Ratio of AUC12,ss Following IV Administration Relative to AUC12,ss Following Oral Administration1.077 ± 0.5470.648 ± 0.0150.476 ± NA
SecondaryArea 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

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
Reported as:
Geometric mean · μg*h/mL
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
μg*h/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
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 Administration66.50 ± 3080.99 ± 4140.00 ± 2
SecondaryMaximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
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
Reported as:
Geometric mean · mcg/mL
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
mcg/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration6.381 ± 288.066 ± 343.835 ± 1
SecondaryTime to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
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
Reported as:
Median · hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
hrsParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration5.05 (2.87 to 11.8)4.49 (1.00 to 11.1)3.84 (1.67 to 6.00)
SecondaryArea 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

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
Reported as:
Geometric mean · μg*h/mL
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
μg*h/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
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 Administration79.86 ± 3690.84 ± 1934.40 ± NA
SecondaryMaximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame:
Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Reported as:
Geometric mean · mcg/mL
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
mcg/mLParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration7.971 ± 318.912 ± 223.720 ± NA
SecondaryTime to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Time frame:
Day 14 (the 7th day of oral treatment) or later: predose, and 1, 2, 4, 6, 8, and 12 hours after dosing
Reported as:
Median · hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
hrsParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
Time to Reach Maximum Observed Plasma Concentration (Tmax) of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration2.07 (0.000 to 7.78)2.03 (0.950 to 4.00)3.80 (3.80 to 3.80)

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants Aged 2 to <12 Years—0/15 (0%)13/15 (86.7%)
Participants Aged 12 to<15 Years and Weighed <50 kg—0/4 (0%)4/4 (100%)
Participants Aged 12 to<15 Years and Weighed ≥50 kg—0/2 (0%)1/2 (50%)
Most frequent other events
Showing 10 of 46
Most frequent other events
EventParticipants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kg
PhotophobiaEye disorders5/153/41/2
Febrile neutropeniaBlood and lymphatic system disorders10/152/41/2
Anorectal disorderGastrointestinal disorders0/150/41/2
Alanine aminotransferase increasedInvestigations1/152/40/2
Aspartate aminotransferase increasedInvestigations1/152/40/2
RashSkin and subcutaneous tissue disorders3/150/41/2
ChromatopsiaEye disorders0/151/40/2
ConjunctivitisEye disorders0/151/40/2
KeratitisEye disorders0/151/40/2
Vision blurredEye disorders0/151/40/2

Baseline characteristics

Age, Continuous
Age, Continuous(years)Participants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kgTotal
Mean7.7 ± 2.812.5 ± 0.614.0 ± 0.09.2 ± 3.4
Sex: Female, Male
Sex: Female, Male(Participants)Participants Aged 2 to <12 YearsParticipants Aged 12 to<15 Years and Weighed <50 kgParticipants Aged 12 to<15 Years and Weighed ≥50 kgTotal
Female92112
Male6219
08

Study locations

6 sites
  • Japanese Red Cross Nagoya Daiichi Hospital
    Nagoya, Aichi, Japan
  • National hospital Organization Nagoya Medical Center
    Nagoya, Aichi, Japan
  • Sapporo Hokuyu Hosipital
    Sapporo, Hokkaido, Japan
  • Kanagawa Children's Medical Center
    Yokohama, Kanagawa, Japan
  • Osaka Medical Center and Research Institute for Maternal and Child Health
    Izumi, Osaka, Japan
  • Dokkyo Medical University Hospital
    Shimotsuga-gun, Tochigi, Japan
09

References and documents

Publications

  • 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. PubMed 25451051 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01383993
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jun 28, 2011
Start date
Sep 2011
Primary completion
May 2013
Completion
May 2013
Results posted
May 9, 2014
Last update
May 9, 2014

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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