Study Evaluating rFIX; BeneFIX® in Hemophilia B

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).

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