Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft Vs. Host Disease (COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses
Intervention: Posaconazole oral suspension (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Schering-Plough
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 Details
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.
Eligibility
Minimum age: 13 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hematopoietic progenitor cell transplant subjects with chronic or Grade II-IV acute
GVHD being treated with high dose immunosuppressive therapy.
- One of the following to the subject's prior immunosuppressive regimen:
1. at least 1mg per kg per day of methylprednisolone or equivalent,
2. Antithymocyte globulin (ATG) for the therapy of acute GVHD,
3. Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive
regimen.
Locations and Contacts
Additional Information
Starting date: February 1998
Ending date: December 2003
Last updated: May 31, 2006
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