Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
The primary objective of the study is to evaluate the long-term safety of recombinant human
 Factor VIII Fc fusion protein (rFVIIIFc) in participants with hemophilia A. The secondary
 objective of the study is to evaluate the efficacy of rFVIIIFc in the prevention and
 treatment of bleeding episodes in participants with hemophilia A.
Participant will follow either a prophylaxis or on-demand regimen. The starting dose in this
 study will be determined by the clinical profile of the participant in the preceding studies
 A-LONG - 997HA301 (NCT01181128), pediatric study 8HA02PED (NCT01458106), 997HA307
 (NCT02083965) and 997HA309 (NCT02502149).
Key Inclusion Criteria:

 -  Subjects who have completed previous rFVIIIFc studies (NCT01181128, NCT02083965,
 NCT01458106 and NCT02502149)

 -  Ability to understand purposes and risks of the study and to provide signed and dated
 informed consent (or assent, as applicable).

 Key Exclusion Criteria:

 -  Confirmed positive high-titer inhibitor (≥5.00 BU/mL).

 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply