A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

Inclusion Criteria

• •For previously treated subjects, either:
• •Completed a CSL-sponsored rIX-FP (CSL654) study, including study CSL654\_3001 \[NCT01496274\] or study CSL654\_3002 \[NCT01662531\].
• •Or:
• •Scheduled to have a major non-emergency surgery within approximately 8 weeks from the anticipated date of receiving the first rIX-FP injection.
• •Not previously completed a CSL-sponsored rIX-FP lead-in study.
• •Male, 12 to 70 years of age.
• •Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
• •Subjects who have received FIX products (plasma-derived and / or recombinant FIX) for \> 150 exposure days (EDs), confirmed by their treating physician.
• •No confirmed history of FIX inhibitor formation at screening by the central laboratory
• •For previously untreated subjects:
• •Male, up to 18 years of age.
• •Documented severe hemophilia B (FIX activity of ≤ 2%), or confirmed at screening by the central laboratory.
• •Never previously been treated with FIX clotting factor products (except previous exposure to blood components).
• •No confirmed history of FIX inhibitor formation
• •Surgery substudy inclusion criterion:
• •Must require non-emergency surgery
• •Male, at least 18 years of age.
• •Subjects currently enrolled in Study CSL654\_3003
• •Subjects who have received rIX-FP for ≥ 100 EDs (single-dose cohorts) or for ≥ 50 EDs (repeated-dose cohort)