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: 17 Apr 2018

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; Shire
  • Most Recent Events

    • 17 Apr 2018 According to a Shire media release, based on data from this study the U.S. Food and Drug Administration (FDA) has approved VONVENDI [von Willebrand factor (recombinant)], a recombinant von Willebrand factor (rVWF) treatment for perioperative management of bleeding in adults (age 18 and older) with von Willebrand disease (VWD).
    • 12 Dec 2017 Results of post-hoc analysis of this and other two studies, presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 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.
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