A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease

Trial Profile

A Phase 3, Prospective, Multicenter Study to Evaluate Efficacy and Safety of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Elective Surgical Procedures in Subjects With Severe Von Willebrand Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2017

At a glance

  • Drugs Vonicog alfa (Primary) ; Rurioctocog alfa
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Acronyms HAEM 3911
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter Innovations GmbH
  • 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 243677) supported the application.
    • 02 Dec 2016 Topline results published in a Shire media release.
    • 02 Dec 2016 Primary endpoint (Hemostatic efficacy) has been met as per Shire media release.
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