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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).
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Ages Eligible for Study:
12 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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