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

Completed · Phase 2/Phase 3

Conditions studied: Hemophilia A With Inhibitors

In brief

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.

Key facts

Study ID

NCT00221195

Run by

Tulane University School of Medicine

People needed

34

Starts

2003-06-01

Expected to finish

2010-07-01

Last updated by the study team

2020-03-02

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet count less than 100,000

Where it is running

• Tulane University School of Medicine — New Orleans, Louisiana, United States

Full record on ClinicalTrials.gov

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