Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
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.
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.
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.