Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Wyeth

Status and phase: Completed; Phase 4

Conditions: Hemophilia B

Treatments: Drug: Recombinant Factor IX Coagulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581126

3090A-100932

Details and patient eligibility

About

To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Full description

Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX < 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")*.

* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

Enrollment: 14 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
2. HIV seropositive ( asymptomatic) or seronegative subjects.
3. No history or detectable inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Description:

Patients will receive Benefix IV according to blood amount

Treatment:

Drug: Recombinant Factor IX Coagulation