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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: 16 Feb 2026

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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 Feb 2026 According to Sobi media release, data from the trial will be presented at the 19th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), taking place 3-6 February 2026 in Dublin, Ireland.
  • 05 Dec 2025 According to Sobi media release, interim analysis of the Phase 3 XTEND-ed long-term extension study will be shared in an Oral Presentation at the 65th American Society of Hematology (ASH) Annual Meeting, taking place on 6 - 9 December in Orlando, Florida.
  • 20 Jun 2025 According to data from this study ,data from this study presented at at the annual International Society on Thrombosis and Haemostasis (ISTH) Congress in Washington (21-25 June).

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