Status:
COMPLETED
Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
Lead Sponsor:
Tulane University School of Medicine
Conditions:
Hemophilia A With Inhibitors
Eligibility:
All Genders
24+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patient...
Eligibility Criteria
Inclusion
- hemophilia A, any severity, with documented history of high-titer inhibitor (\>5BU); current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; \>/= 6 bleeds requiring bypassing therapy in the previous 6 months
Exclusion
- concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00221195
Start Date
June 1 2003
End Date
July 1 2010
Last Update
March 2 2020
Active Locations (1)
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1
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112