Hemophilia B
Conditions
Keywords
BENEFIX, 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.
Interventions
DRUGRecombinant Factor IX Coagulation
Benefix IV each 12 hours for 2 a 5 days
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding. | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| The secondary variables will be hemostasis and blood loss during and after surgery. | 9 months |
Outcome results
None listed