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

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2017

At a glance

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

    • 22 Jun 2017 According to a Shire media release, the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for VEYVONDI to prevent and treat bleeding episodes and peri-operative bleeding in adults (age 18 and older) diagnosed with von Willebrand Disease (VWD). Data from this and another phase III trial (profile 251088) supported the application.
    • 10 Jun 2017 Biomarkers information updated
    • 08 Dec 2015 Results of pooled analaysis from this and other phase I trial (n=56), presented at the 57th Annual Meeting and Exposition of the American Society of Hematology.
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