- Documented history of moderately severe or severe hemophilia B (FIX:C less than or
equal to 2%)
- Male subjects, aged 6 years to 65 years.
- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in
the 12 months before screening.
- Subjects currently utilizing FIX primary prophylaxis.
- Subjects with HIV+ who have a CD4 count less than 200
- Subjects with hepatic or renal impairment.
- Prothrombin time or International Normalized Ration more than 1.5 times the upper
limit of normal.
- Major surgery or an orthopedic surgical procedure within the past 3 months or is
planned within the duration of participation in this study.
- Past history of, or current FIX inhibitor.
- Hypersensitivity to any FIX product or hamster protein.
- Exposure to any investigational drug, except for rFIX-R, or device within 30 days of
providing consent/assent (as appropriate) for this study.
- Bleeding disorders other than hemophilia B.
- Concurrent inflammatory disease that in the investigator's judgment could confound the