- Male and/or female subjects with hemophilia B.
- Subjects/parents/legal representatives must be able to comply with study procedures
(informed consent/assent process, clinical visits, reporting of infusion and bleed
data, reporting of adverse events, etc)
- Presence of any other bleeding disorder in addition to hemophilia B. Subjects with a
past history of, or current factor IX inhibitor. For laboratory-based assessments,
any Bethesda inhibitor titer greater than the laboratory's normal range or ?0.6
Bethesda Unit (BU)/mL.
- Subjects with known hypersensitivity to the active substance or to any of the
excipients of BeneFIX.
- Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.