Hemophilia B Clinical Trial
Official title:
An Open-label Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Previously Treated Patients (PTPs) With Hemophilia B (FIX:C ≤2%)
The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | May 2005 |
| Est. primary completion date | May 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Hemophilia B (FIX:C less than 2%) - Previous treatment of at least 150 exposure days using any FIX product - 12 years of age and older Exclusion Criteria: - The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient) - Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins - Patient has a genetic coagulation disorder other than hemophilia B |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
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