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NCT00034645 Clinical Trial

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

Mycoses Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034645
Other study ID # C98316
Secondary ID C/I98-316
Status Completed
Phase Phase 3
First received May 1, 2002
Last updated March 7, 2017
Start date January 1999
Est. completion date February 2003

Study information
Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date February 2003
Est. primary completion date February 2003
Accepts healthy volunteers No
Gender All
Age group 13 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Posaconazole oral suspension

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.
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