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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

NCT01454739

CompletedPhase 3

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Hemophilia A

Interventions: rFVIIIFc

Countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany

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.

Eligibility overview

Sex: MALE

Age: 0 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (78)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • San Diego, California, United States
  • Washington D.C., District of Columbia, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • New Orleans, Louisiana, United States
  • Boston, Massachusetts, United States
  • East Lansing, Michigan, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Chapel Hill, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Portland, Oregon, United States
  • Philadelphia, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Camperdown, New South Wales, Australia
  • South Brisbane, Queensland, Australia
  • Adelaide, South Australia, Australia
  • Melbourne, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Subiaco, Western Australia, Australia
  • Vienna, Austria
  • + 48 more on CT.gov