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

Tulane University School of Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hemophilia A With Inhibitors

Treatments: Drug: activated prothrombin complex concentrate (FEIBA)

Study type: Interventional

Funder types: Other

Identifiers

NCT00221195

PRO-FEIBA Study

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 24+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

On-demand first

Other group

Description:

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

Treatment:

Drug: activated prothrombin complex concentrate (FEIBA)

Prophylaxis first

Other group

Description:

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

Treatment:

Drug: activated prothrombin complex concentrate (FEIBA)