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

Inclusion Criteria:

- Male subjects, 12 to 65 years old

- Severe hemophilia B (FIX activity of ≤ 2%)

- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs)

- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX

- Written informed consent for study participation

- On-demand subjects only, who have experienced a minimum average of 2 non-trauma
induced bleeding episodes requiring treatment with a FIX product during the previous
6 or 3 months

Exclusion Criteria:

- Known hypersensitivity to any FIX product or hamster protein

- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency

- HIV positive subjects with a CD4 count < 200/mm3

- Low platelet count, kidney or liver dysfunction

- Recent life-threatening bleeding episode