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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

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.