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Home > "P" Clinical Trials Conditions > Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease  Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
For Condition: Mycoses
Status: Completed
Sponsor(s): Schering-Plough ,
Synopsis: This trial is in high risk patients to determine the safety and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).
Details: 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 13 Years/65 Years
Genders: Both
Protocol Entry 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: (a) at least 1mg per kg per day of methylprednisolone or equivalent, (b) Antithymocyte globulin (ATG) for the therapy of acute GVHD, (c) Tacrolimus, mycophenolate mofetil, or other steroid-sparing immunosuppressive regimen.
Total Enrollment: 600
Location and Contact Information:
Hospital Das Clinicas Da UFMG
Belo Horizonte, ,
Brazil
University Hospital of Wales
Cardiff, Wales,
United Kingdom
Department of Hematology and BMT
Katowice, ,
Poland
University of Maryland
Baltimore, Maryland,
United States
Additional Information:
Study ID Numbers: C/I98-316;
Study Start Date: February 1998
Record last reviewed: May 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034645
Other Mycoses Studies:
1. Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)
2. Phase I Study of the Safety, Tolerance, and Pharmacokinetics of FK463 in Immunocompromised Children with Fever and Neutropenia
3. Voriconazole to Prevent Systemic Fungal Infections in Children
4. Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections
5. Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
Related Studies:
Other Mycoses Clinical Trials
Other Clinical Trials
Other Katowice Clinical Trials
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients with Graft vs. Host Disease
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