Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
Phase 2
Completed
- Conditions
- Hemophilia A With Inhibitors
- Interventions
- Drug: activated prothrombin complex concentrate (FEIBA)
- Registration Number
- NCT00221195
- Lead Sponsor
- Tulane University School of Medicine
- 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 patients with hemophilia and persistent high responding inhibitors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- 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 Criteria
- concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description On-demand first activated prothrombin complex concentrate (FEIBA) Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug Prophylaxis first activated prothrombin complex concentrate (FEIBA) Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
- Primary Outcome Measures
Name Time Method Number of Bleeds During 6 Month Treatment Period 6 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States