- Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe
hemophilia B (Factor IX activity ≤2%).
- Subjects should not have received an infusion of any Factor IX products for at least 4
days before the administration of BeneFIX on Day 1.
- Subjects must be in a non-bleeding state before the administration of BeneFIX on Day
1.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
allergies at time of dosing) disease or clinical findings at Screening.
- Diagnosed with any other bleeding disorder in addition to hemophilia B.
- Current FIX inhibitor or history of FIX inhibitor (defined as > Upper Limit of Normal
(ULN) of the reporting lab).