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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of FEIBA in inhibiting bleeding episodes in Hemophilia A patients with high-titer inhibitors?
How does activated prothrombin complex concentrate compare to bypassing agents like rFVIIa in managing hemophilia A with inhibitors?
Which biomarkers correlate with FEIBA response in patients with persistent high responding inhibitors to factor VIII?
What adverse events are associated with long-term FEIBA use in Hemophilia A with Inhibitors phase 2 trials?
Are there combination therapies involving FEIBA and immune tolerance induction protocols for hemophilia A inhibitor management?
Trial Locations
- Locations (1)
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Tulane University School of Medicine🇺🇸New Orleans, Louisiana, United States