Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes
The primary objective of the study is to evaluate the effectiveness of prophylactic treatment
 with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion
 protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes
 while maintaining disease control in males with hemophilia A or B.
Key Inclusion Criteria:

 -  Have a medically documented diagnosis of hemophilia A or B that is being treated
 prophylactically with a factor replacement product not designed to have a prolonged
 half-life and satisfy a therapeutic indication for rFVIIIFc/rFIXFc per the approved
 local label

 -  Have at least 50 prior exposure days (EDs) to any combination of factor replacement
 products

 -  Have documented pre-study data available that confirm fulfillment of the eligibility
 criteria

 -  Have no measurable inhibitor activity in a sample obtained within 4 weeks prior to the
 Baseline visit, and absence of clinical signs or symptoms of decreased response to the
 current factor replacement product

 Key Exclusion Criteria:

 -  Have a diagnosis of any bleeding disorder other than hemophilia A or hemophilia B or
 an additional coagulation disorder(s) in addition to hemophilia A or hemophilia B

 -  Have a prior history of anaphylaxis associated with any factor VIII (FVIII)/ factor IX
 (FIX) or intravenous immunoglobin administration

 -  Had an inhibitor within 5 years before the Baseline visit. Note: A family history of
 inhibitors will not exclude the patient.

 -  Past or current treatment with any factor replacement product with a prolonged
 half-life, including an Fc product, for the treatment of hemophilia

 NOTE: Other Protocol Defined Inclusion/ Exclusion Criteria May Apply.