Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects 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).
Number of Participants With Any Positive Inhibitor Development
Annualized Bleeding Rate (ABR)
Study Arms / Comparison Groups
Description: The individual dose of rFVIIIFc to treat bleeding episodes will be based on participant's clinical condition, type and severity of the bleeding event, and if indicated, Factor VIII (FVIII) levels.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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
0 Years - N/A
Accepts Healthy Volunteers
Medical Director, ,
Bioverativ Therapeutics Inc.
Medical Director, Study Director, Bioverativ Therapeutics Inc.