Phase 3
Completed N=34
Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors
Hemophilia A With Inhibitors
Source: ClinicalTrials.gov NCT00221195 ↗
Enrolled (actual)
34
Serious AEs
12.1%
Results posted
Feb 2017
Primary outcomePrimary: Number of Bleeds During 6 Month Treatment Period — 13.1; 5.0 bleeds — p=<0.001
◆ Published Evidence
Highly cited
▲ Trending
220citations · ~15 / year
Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors.
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.
Linked Publications (2)
-
Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors.
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Health-related quality of life in patients with haemophilia and inhibitors on prophylaxis with anti-inhibitor complex concentrate: results from the Pro-FEIBA study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Bleeds During 6 Month Treatment Period |
13.1; 5.0 | <0.001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00221195) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.