EUCTR2012-001151-39-Outside-EU/EEAActive, not recruitingNot Applicable
An Open Label, Intravenous to Oral Switch, Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Voriconazole in Immunocompromised Adolescents Aged 12 to <17 Years who are at High Risk for Systemic Fungal Infection
Pfizer Inc. 235 East 42nd Street, New York, NY 100170 sites26 target enrollmentStarted: March 6, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Male or female from 12 to <17 years of age.
- •Require treatment for the prevention of systemic fungal infection.
- •Expected to develop neutropenia (ANC <500 cells/µL) lasting more than 10 days following chemotherapy.
- •Anticipated to live for more than 3 months.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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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