Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Completed
Biogen
Phase 3
2011-12-01
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.
Long-Term Safety and Efficacy of rFVIIIFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia A
Completed
Bioverativ Therapeutics Inc.
Phase 3
2011-12-01
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.
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
Completed
Swedish Orphan Biovitrum
Phase 3
2012-11-01
The primary objective of the study is to evaluate the safety of Recombinant Coagulation
Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with
hemophilia A. Secondary objectives of this study in this study population are as follows: to
evaluate the efficacy of rFVIIIFc for prevention and treatment of bleeding episodes; to
evaluate and assess the pharmacokinetics (PK) of rFVIIIFc; and to evaluate rFVIIIFc
consumption for prevention and treatment of bleeding episodes.
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