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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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Trial Profile

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: 23 Jul 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

    • 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.
    • 27 Oct 2023 Planned primary completion date changed from 12 Feb 2027 to 15 Jan 2027.

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