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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 Pediatric 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 Pediatric Patients <12 Years of Age With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2024

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At a glance

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

    • Most Recent Events

    • 18 Jul 2024 According to Sobi media release, announced the publication of full results from the Phase 3 XTEND-Kids study in The New England Journal of Medicine (NEJM) confirming the safety and efficacy profile
    • 17 Jul 2024 According to Sanofi media release, data from this trial published in The New England Journal of Medicine (NEJM)
    • 17 Jul 2024 Results published in the Sanofi Media Release
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