Clinical Trial: Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With 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.

Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding. [ Time Frame: 9 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary variables will be hemostasis and blood loss during and after surgery. [ Time Frame: 9 months ]

Original Secondary Outcome: Same as current

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: December 21, 2007
Date Started: December 2001
Date Completion:
Last Updated: December 26, 2007
Last Verified: December 2007