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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 3

Conditions

Mycoses

Treatments

Drug: Posaconazole oral suspension

Study type

Interventional

Funder types

Industry

Identifiers

NCT00034645

C/I98-316 (Other Identifier)

C98316

Details and patient eligibility

About

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).

Full 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.

Enrollment

600 patients

Sex

All

Ages

13 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.