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A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

Trial Profile

A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Nov 2019

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At a glance

  • Drugs Vonicog alfa (Primary) ; Octocog alfa
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter Innovations GmbH
  • Most Recent Events

    • 19 Jun 2019 This trial has been completed in Spain as per European Clinical Trials Database record.
    • 12 Sep 2018 According to the Shire media release, based on the data from this and other two trials (700251088 and 700244574), the European Commission (EC) has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor (rVWF)] for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or not indicated.
    • 31 Aug 2018 Biomarkers information updated
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