Brief Title
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
Official Title
Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.
Secondary Outcome
The secondary variables will be hemostasis and blood loss during and after surgery.
Condition
Hemophilia B
Intervention
Recombinant Factor IX Coagulation
Study Arms / Comparison Groups
1
Description: Patients will receive Benefix IV according to blood amount
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
14
Start Date
December 2001
Completion Date
July 2004
Eligibility Criteria
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.
Gender
All
Ages
6 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Administrative Informations
NCT ID
NCT00581126
Organization ID
3090A-100932
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
December 2007