Pharmacokinetics of rFVIIIFc at Two Vial Strengths

This will be a randomized, open-label, crossover study during which each participant will
receive a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment).
After the PK assessment, participants will be provided with rFVIIIFc for either prophylactic
or episodic (on-demand) treatment for up to 6 months.

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