BAX 326 Surgery Study in Hemophilia B Patients

Exclusion Criteria

• •Participant 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.
• •Participant has a detectable FIX inhibitor at screening, with a titer ≥0.6 Bethesda Units (BU) as determined by the Nijmegen modification of the Bethesda assay in the central laboratory.
• •Participant has a history of allergic reaction or evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
• •Known hypersensitivity to hamster proteins or recombinant furin.
• •Evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
• •Abnormal renal function
• •Severe chronic liver disease
• •Active hepatic disease with ALT or AST levels \> 5 times the upper limit of normal.
• •Diagnosis of an iherited or acquired hemostatic defect other than hemophilia B.
• •Platelet count \< 100,000/mL.