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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A With Inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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On-demand first

Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug

Group Type OTHER

activated prothrombin complex concentrate (FEIBA)

Intervention Type DRUG

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Prophylaxis first

Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug

Group Type OTHER

activated prothrombin complex concentrate (FEIBA)

Intervention Type DRUG

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Interventions

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activated prothrombin complex concentrate (FEIBA)

FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Intervention Type DRUG

Eligibility Criteria

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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