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

Tracking Information
First Received Date ^ICMJE	May 1, 2002
Last Updated Date	May 31, 2006
Start Date ^ICMJE	February 1998
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00034645 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft Vs. Host Disease (COMPLETED)
Official Title ^ICMJE	Not Provided
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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Mycoses
Intervention ^ICMJE	Drug: Posaconazole oral suspension
Study Arm (s)	Not Provided
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	600
Completion Date	December 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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: at least 1mg per kg per day of methylprednisolone or equivalent, Antithymocyte globulin (ATG) for the therapy of acute GVHD, Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.
Gender	Both
Ages	13 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00034645
Other Study ID Numbers ^ICMJE	C/I98-316
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	May 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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