Pharmacokinetics and Safety of rFVIIIFc Manufactured at 15,000 L (15K) Scale
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: rFVIIIFc
Intervention description: As per arm description
Intervention MeSH terms: Factor VIII
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: rFVIIIFc; Eloctate; Hemophilia

Summary:

      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.
    

Eligibility criteria:

        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.