PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)
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|ClinicalTrials.gov Identifier: NCT00034671|
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : December 31, 2015
This phase II study will be conducted to:
- evaluate the pharmacokinetics, safety, tolerance, and efficacy of different dosing schedules of Posaconazole in immunocompromised hosts with a variety of refractory invasive fungal infections or in subjects who require empiric antifungal therapy and
- identify the dosing schedule that provides the most consistent therapeutic drug exposure in this patient population.
|Condition or disease||Intervention/treatment||Phase|
|Mycoses||Drug: Posaconazole oral suspension||Phase 2|
This is an open-label, randomized, parallel group, study of pharmacokinetics, safety, tolerance, and efficacy of Posaconazole in the treatment of immunocompromised hosts with refractory invasive fungal infections or in subjects who require empiric antifungal therapy.
The projected number of subjects planned for enrollment is 100 evaluable subjects. The number of planned study sites is approximately ten in the United States and approximately eight in the rest of the world.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Safety, Tolerance, Efficacy, and Pharmacokinetics of Posaconazole (SCH 56592) for the Treatment of Invasive Fungal Infections in Immunocompromised Hosts|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||November 2001|
|Actual Study Completion Date :||March 2002|