A-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A

The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc
administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical
treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm
1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical
treatment regimen. The secondary objectives of this study are: to characterize the PK profile
of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to
characterize the range of dose and schedules required to adequately prevent bleeding in a
prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes
in an on-demand, weekly treatment, or prophylaxis setting.