A Prospective, Randomized, Cross-over Study of an Activated Prothrombin Complex Concentrate for Secondary Prophylaxis in Patients With Hemophilia A and Inhibitors

Tulane University School of Medicine1 site in 1 country34 target enrollmentJune 2003

ConditionsHemophilia A With Inhibitors

Interventionsactivated prothrombin complex concentrate (FEIBA)

Drugsactivated prothrombin complex concentrate (FEIBA)

Overview

Phase: Phase 2
Intervention: activated prothrombin complex concentrate (FEIBA)
Conditions: Hemophilia A With Inhibitors
Sponsor: Tulane University School of Medicine
Enrollment: 34
Locations: 1
Primary Endpoint: Number of Bleeds During 6 Month Treatment Period
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2003

End Date

July 2010

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Tulane University School of Medicine

Responsible Party

Sponsor

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