Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

Main Inclusion Criteria:

• Subject is 12 to 65 years old at the time of screening
• Subject and/or legal representative has/have provided signed informed consent
• Subject has severe (factor IX (FIX) level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time [aPTT] assay), as tested at screening at the central laboratory
• Subject is previously treated with plasma-derived or recombinant FIX concentrate(s) for a minimum of 150 exposure days (EDs)(based on the subject's medical records); if a verifiable, documented history is unavailable, the subject can be enrolled if s/he has participated in Study 050901 for at least 50 EDs to Immunine prior to enrollment (not valid for US and Japan).
• Subject has no evidence of a history of FIX inhibitors

Main Exclusion Criteria:

• The subject has a history of FIX inhibitors with a titer >= 0.6 Bethesda Units (BU) (as determined by the Nijmegen modification of the Bethesda assay or the assay employed in the respective local laboratory) at any time prior to screening
• The subject has a detectable FIX inhibitor at screening, with a titer >= 0.6 BU as determined by the Nijmegen modification of the Bethesda assay in the central laboratory
• The subject's weight is < 35 kg or > 120 kg
• The subject has a history of allergic reaction, eg, anaphylaxis, following exposure to FIX concentrate(s)
• The subject has a known hypersensitivity to hamster proteins or rFurin
• The subject has ongoing or recent evidence of a thrombotic disease, fibrinolysis or DIC