Trials / Completed
CompletedNCT00034645
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 13 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole oral suspension |
Timeline
- Start date
- 1999-01-01
- Primary completion
- 2003-02-01
- Completion
- 2003-02-01
- First posted
- 2002-05-02
- Last updated
- 2017-03-10
Source: ClinicalTrials.gov record NCT00034645. Inclusion in this directory is not an endorsement.