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A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

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A Phase 3 Open-label, Multicenter Study of the Long-term Safety and Efficacy of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients With Severe Hemophilia A

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Dec 2024

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At a glance

  • Drugs Efanesoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Registrational
  • Acronyms XTEND-ed
  • Sponsors Bioverativ; Sanofi

    • Most Recent Events

    • 03 Dec 2024 According to Sobi media release, second interim analysis data from this study will be presented in an oral presentation at at the 66th Annual Meeting of the American Society of Hematology (ASH) in San Diego, CA (USA) from the 7th - 10th of December 2024.
    • 17 Jun 2024 According to Sobi media release, data from this trial will be presented at ISTH 2024, the 32nd Congress of the International Society on Thrombosis and Haemostasis. This event, taking place from 22nd to 26th June.
    • 27 Oct 2023 Planned End Date changed from 12 Feb 2027 to 15 Jan 2027.

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