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

Phase 3

Completed

• Conditions: Mycoses

• Registration Number: NCT00034645
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Study Timeline

• Study Start: 1999-01
• Study First Submitted: 2002-05-01
• Study First Submitted QC: 2002-05-01
• Study First Posted: 2002-05-02
• Primary Completion: 2003-02
• Study Completion: 2003-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL