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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: 26 Jun 2025

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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

  • 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).
  • 23 Apr 2025 According to Sobi media release, data from this study presented at WFH 2025 Comprehensive Care Summit in Dubai
  • 28 Jan 2025 According to Sobi media release, A second Interim Analysis from this study to be presented at the annual European Association for Haemophilia and Allied Disorders (EAHAD 2025) congress in Milan from the 4th - 7th February, 2025.

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