Phase 3 N=34 Randomized Prevention

Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors

Hemophilia A With Inhibitors

Bottom Line

View on ClinicalTrials.gov: NCT00221195 ↗

Enrolled (actual)

Serious AEs

12.1%

Results posted

Feb 2017

Primary outcome: Primary: Number of Bleeds During 6 Month Treatment Period — 13.1; 5.0 bleeds — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: activated prothrombin complex concentrate (FEIBA) (Drug)
Age: Pediatric, Adult, Older Adult · 0+ yrs
Sex: All
Sponsor: Tulane University School of Medicine
Primary completion: Dec 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Bleeds During 6 Month Treatment Period	13.1; 5.0	<0.001 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00221195). 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.