Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Phase 4

Completed

• Conditions: Hemophilia B
• Interventions: Drug: Recombinant Factor IX Coagulation

• Registration Number: NCT00581126
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-12
• Study Completion: 2004-07
• Status Verified: 2007-12
• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-26
• Last Update Submitted: 2007-12-26
• Study First Posted: 2007-12-27
• Last Update Posted: 2007-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Recombinant Factor IX Coagulation	Patients will receive Benefix IV according to blood amount

Primary Outcome Measures

Name	Time	Method
The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.	9 months

Secondary Outcome Measures

Name	Time	Method
The secondary variables will be hemostasis and blood loss during and after surgery.	9 months