Back to resultsProphylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
Primary Purpose
Mycoses
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Posaconazole oral suspension
Sponsored by
About this trial
This is an interventional prevention trial for Mycoses focused on measuring Allogenic Stem cell transplantation, Fungal infections
Eligibility 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: 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00034645
Brief Title
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses
Keywords
Allogenic Stem cell transplantation, Fungal infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Posaconazole oral suspension
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
17251530
Citation
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. doi: 10.1056/NEJMoa061098. Erratum In: N Engl J Med. 2007 Jul 26;357(4):428.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease
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