Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
The primary objective of the study is to compare the pharmacokinetic (PK) of recombinant
 coagulation factor VIII Fc fusion protein (rFVIIIFc) manufactured at the current scale of
 2000 L (2K) to the PK of rFVIIIFc manufactured at the 15,000 L (15K) scale in previously
 treated participants with severe hemophilia A. The secondary objectives are: to characterize
 the PK of rFVIIIFc manufactured at the 15K scale at the 15K baseline and after 13 weeks of
 treatment; to characterize the PK of rFVIIIFc manufactured at the 15K scale at 1000 IU/vial
 and 6000 IU/vial strengths; and to evaluate the safety of rFVIIIFc manufactured at the 15K
 scale.
PK assessments are in 3 phases: Pharmacokinetic Assessment 1(PK1): PK assessments following
 single injection of rFVIIIFc manufactured at the 2K scale. Pharmacokinetic Assessment 2
 (PK2): PK assessments are made following a single injection of rFVIIIFc manufactured at the
 15K scale where participants are randomized to the 1000 IU vial or 6000 IU/vial strengths.
 Pharmacokinetic Assessment 3 (PK3): PK assessments are made following 13 weeks of rFVIIIFc
 treatment manufactured at the 15K scale where participants are randomized to the 1000 IU vial
 or 6000 IU/vial strengths. After study completion, in countries where rFVIIIFc is not
 commercially available, eligible participants will be offered enrollment into a long-term
 safety and efficacy extension study (8HA01EXT [NCT01454739]).
Key Inclusion Criteria:

 -  Have severe hemophilia A, defined as <1 IU/dL (<1%) endogenous FVIII as determined by
 one-stage clotting assay from the central laboratory at Screening.

 -  Previously treated subject, defined as having at least 150 documented prior exposure
 days (EDs) to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate
 products 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 the subject.

 -  No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (>=0.6
 Bethesda Unit per milliliter [BU/mL] is considered positive) at Screening.

 Key Exclusion Criteria:

 -  Current enrollment in any interventional clinical study in which an investigational
 drug or approved therapy for investigational use is administered within 30 days prior
 to the Baseline Visit OR prior participation in any of the following Biogen studies:
 998HA101 (NCT01027377), 997HA301 (NCT01181128), 8HA02PED (NCT01458106), 997HA307
 (NCT02083965), and 8HA01EXT (NCT01454739).

 -  Previous participation in this study.

 -  Any concurrent clinically significant major disease that, in the opinion of the
 Investigator or Biogen, makes the subject unsuitable for participation in the study.

 -  Other coagulation disorder(s) in addition to hemophilia A.

 -  History of hypersensitivity or anaphylaxis associated with FVIII or intravenous (IV)
 immunoglobulin administration.

 NOTE: Other protocol-defined inclusion/exclusion criteria may apply.