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

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT00034645
Collaborator
(none)
600
Enrollment
49
Duration (Months)

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Posaconazole oral suspension
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Study Start Date :
Jan 1, 1999
Actual Primary Completion Date :
Feb 1, 2003
Actual Study Completion Date :
Feb 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Merck Sharp & Dohme LLC

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck Sharp & Dohme LLC
    ClinicalTrials.gov Identifier:
    NCT00034645
    Other Study ID Numbers:
    • C98316
    • C/I98-316
    First Posted:
    May 2, 2002
    Last Update Posted:
    Mar 10, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by Merck Sharp & Dohme LLC
    Allogenic Stem cell transplantation
    Fungal infections
    Additional relevant MeSH terms:
    Mycoses
    Posaconazole

    Study Results

    No Results Posted as of Mar 10, 2017