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An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

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Trial Profile

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

  • Drugs Eftrenonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Registrational; Therapeutic Use
  • Acronyms PUPs B-LONG
  • Sponsors Biogen; Bioverativ

Most Recent Events

  • 14 Dec 2021 Results assessing a descriptive post hoc analysis of spontaneous bleed events in the context of treatment regimen (eg, prophylaxis [PPX] versus on-demand [OD]) in previously untreated participants (PUPs) with hemophilia B treated with extended half-life recombinant factor IX Fc fusion protein (rFIXFc, Alprolix) from the PUPs B-LONG study, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.
  • 08 Nov 2021 According to a Sanofi media release, results from this study will be presented as an oral presentation at the American Society of Hematology (ASH) Annual Meeting, 2021.
  • 08 Dec 2020 Final results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology

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