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Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft Vs. Host Disease (COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00034645
First received: May 1, 2002
Last updated: May 31, 2006
Last verified: May 2006
History of Changes
  Purpose

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 Intervention Phase
Mycoses
 Drug: Posaconazole oral suspension
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Estimated Enrollment: 600
Study Start Date: February 1998
Estimated Study Completion Date: December 2003
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

Ages Eligible for Study:   13 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Schering-Plough

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00034645     History of Changes
Other Study ID Numbers: C/I98-316
Study First Received: May 1, 2002
Last Updated: May 31, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Allogenic Stem cell transplantation
Fungal infections

Additional relevant MeSH terms:
Graft vs Host Disease
Mycoses
Immune System Diseases
Posaconazole
Antifungal Agents
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013