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

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ClinicalTrials.gov Identifier: NCT00034645
Recruitment Status : Completed
First Posted : May 2, 2002
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):

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
Mycoses 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  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Study Start Date : January 1999
Primary Completion Date : February 2003
Study Completion Date : February 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
More Information

Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034645     History of Changes
Other Study ID Numbers: C98316
C/I98-316 ( Other Identifier: Sponsor )
First Posted: May 2, 2002    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Allogenic Stem cell transplantation
Fungal infections

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs