Brief Title
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Official Title
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
Brief Summary
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.
Detailed Description
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).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Any Positive Inhibitor Development
Secondary Outcome
Annualized Bleeding Rate (ABR)
Condition
Hemophilia A
Intervention
rFVIIIFc
Study Arms / Comparison Groups
On-Demand
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
240
Start Date
December 2011
Completion Date
October 2017
Primary Completion Date
October 2017
Eligibility Criteria
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
Gender
Male
Ages
0 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Director, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01454739
Organization ID
8HA01EXT
Secondary IDs
2011-003072-37
Responsible Party
Sponsor
Study Sponsor
Bioverativ Therapeutics Inc.
Study Sponsor
Medical Director, Study Director, Bioverativ Therapeutics Inc.
Verification Date
November 2018