NCT00581126

Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
DRUG	Recombinant Factor IX Coagulation	Benefix IV each 12 hours for 2 a 5 days

Timeline

• Start date: 2001-12-01
• Completion: 2004-07-01
• First posted: 2007-12-27
• Last updated: 2007-12-27