BAX 326 Surgery Study

• Intraoperative hemostatic efficacy [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
  Assessment on a scale of "excellent", "good", "fair" and "none"
• Actual intraoperative blood loss [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
  Actual intraoperative blood loss compared to average and maximum blood loss predicted preoperatively by the operating surgeon

• Postoperative hemostatic efficacy [ Time Frame: At time of drain removal, if applicable, or approx. 72 hours postoperatively ] [ Designated as safety issue: No ]
  Assessment on a scale of "excellent", "good", "fair" and "none"
• Actual postoperative blood loss [ Time Frame: At time of drain removal, if applicable, or approx. 72 hours postoperatively ] [ Designated as safety issue: No ]
  Actual postoperative blood loss until drain removal, if applicable, compared to average and maximum blood loss predicted preoperatively by the operating surgeon
• Development of inhibitory and total binding antibodies to FIX [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
• Adverse events related to BAX 326 [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]
• Occurrence of thrombotic events [ Time Frame: 3 years (at study completion) ] [ Designated as safety issue: Yes ]

The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level < 1%) or moderately severe (FIX level <= 2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.

Main Inclusion Criteria:

• Subject and/or legal representative has/have voluntarily provided signed informed consent.
• Subject has severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage aPTT assay), as tested at screening at the central laboratory.
• Subject is immunocompetent as evidenced by a CD4 count >= 200 cells/mm3.
• Subject is human immunodeficiency (HIV) negative or is HIV+ with a viral load < 200 particles/μL ~ < 400,000 copies/mL.

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 has a history of allergic reaction or evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).