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Clinical Trials/JPRN-jRCT2080221537
JPRN-jRCT2080221537UnknownPhase 2

An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 Years Who Are At High Risk For Systemic Fungal Infection(A1501096)

Pfizer Japan Inc.0 sites20 target enrollmentStarted: August 9, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
20
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label

Eligibility Criteria

Ages
>= 2age old to <= 15age old (—)
Sex
All

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.

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.

Investigators

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