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

This study has been completed.

First Received on May 1, 2002. Last Updated on May 31, 2006 History of Changes

Sponsor:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00034645

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 III

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:

MedlinePlus related topics: Fungal Infections Molds

Drug Information available for: Posaconazole

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):

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.

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 February 12, 2012