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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.|
- The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- The secondary variables will be hemostasis and blood loss during and after surgery. [ Time Frame: 9 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2001|
|Study Completion Date:||July 2004|
Patients will receive Benefix IV according to blood amount
Drug: Recombinant Factor IX Coagulation
Benefix IV each 12 hours for 2 a 5 days
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.