Pharmacokinetics of rFVIIIFc at Two Vial Strengths
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc
 administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The
 secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK
 assessment for up to 6 months for a continued treatment period.
This is a randomized, open-label, crossover study during which each participant receives a
 single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the
 PK assessment, participants are 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