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Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

Mycoses Clinical Trial

Clinical Trial Summary

This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

Clinical Trial Description

This study is designed to determine the safety, tolerance and efficacy of POZ used as prophylaxis of IFI in high-risk subjects with Grade II-IV acute graft vs. host disease (GVHD) or extensive chronic GVHD. The primary objective is to assess the efficacy of SCH56592 vs fluconazole in preventing proven or probable IFI within the time period from randomization to 16 weeks after the start of treatment with study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00034645
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Completed
Phase Phase 3
Start date January 1999
Completion date February 2003
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