Pharmacokinetics of rFVIIIFc at Two Vial Strengths

Key Inclusion Criteria:

• Have severe hemophilia A
• Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
• No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
• No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
• Platelet count ≥100,000 platelets/μL at screening
• CD4 lymphocytes >200 mm3 if known as HIV antibody positive at screening.
• Viral load of <400 copies/mL if known HIV antibody positive at screening.

Key Exclusion Criteria:

• Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
• Previous treatment with rFVIIIFc as study drug or commercial product.
• Other coagulation disorder(s) in addition to hemophilia A.
• History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
• Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
• Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.

NOTE: Other protocol-defined inclusion/exclusion Criteria May Apply