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A Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A

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Trial Profile

A Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTEN; BIVV001) in Previously Treated Patients ≥12 Years of Age With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2025

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At a glance

  • Drugs Efanesoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms XTEND-1
  • Sponsors Bioverativ

    • Most Recent Events

    • 28 Jan 2025 According to Sobi media release, data 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.
    • 03 Dec 2024 According to Sobi media release, result 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.
    • 19 Jun 2024 According to Sobi media release, the European Commission also endorsed the European Medicines Agency (EMA) recommendation supporting ALTUVOCTs retention of orphan drug designation, granting a 10-year market exclusivity period based on the results from the XTEND-1 and XTEND-Kids studies.

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