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An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

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Trial Profile

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Apr 2022

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At a glance

  • Drugs Efmoroctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms PUPs A-LONG
  • Sponsors Biogen; Bioverativ

    • Most Recent Events

    • 12 Apr 2022 Results assessing safety and efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in previously untreated patients (PUPs) with hemophilia A published in the Blood
    • 08 Dec 2020 Final Results evaluating Safety and Efficacy of recombinant factor VIII Fc fusion protein (rFVIIIFc) in Previously Untreated Patients with Haemophilia A, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 13 Jul 2020 Results presented in the Swedish Orphan Biovitrum media release.

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