Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Brief Title

Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Official Title

Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.

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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.

Secondary Outcome

 The secondary variables will be hemostasis and blood loss during and after surgery.

Condition

Hemophilia B

Intervention

Recombinant Factor IX Coagulation

Study Arms / Comparison Groups

Description:  Patients will receive Benefix IV according to blood amount

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

December 2001

Completion Date

July 2004

Eligibility 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.

Gender

All

Ages

6 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Medical Monitor, ,

Administrative Informations

NCT ID

NCT00581126

Organization ID

3090A-100932

Study Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study Sponsor

Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

December 2007