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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034645
First Posted: May 2, 2002
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
May 1, 2002
May 2, 2002
March 10, 2017
January 1999
February 2003   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00034645 on ClinicalTrials.gov Archive Site
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Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
Not Provided
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).
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Mycoses
Drug: Posaconazole oral suspension
Not Provided
Ullmann AJ, Lipton JH, Vesole DH, Chandrasekar P, Langston A, Tarantolo SR, Greinix H, Morais de Azevedo W, Reddy V, Boparai N, Pedicone L, Patino H, Durrant S. Posaconazole or fluconazole for prophylaxis in severe graft-versus-host disease. N Engl J Med. 2007 Jan 25;356(4):335-47. Erratum in: N Engl J Med. 2007 Jul 26;357(4):428.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
February 2003
February 2003   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Argentina,   Australia,   Austria,   Brazil,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Italy,   Mexico,   Netherlands,   Peru,   Poland,   Portugal,   Saudi Arabia,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
 
NCT00034645
C98316
C/I98-316 ( Other Identifier: Sponsor )
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP