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: 12 Sep 2018

At a glance

  • Drugs Vonicog alfa (Primary) ; Octocog alfa
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Acronyms HAEM 3911
  • Sponsors Baxalta; Baxter Healthcare Corporation; Shire
  • Most Recent Events

    • 12 Sep 2018 According to the Shire media release, based on the data from this and other two trials (700243677 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.
    • 02 Jul 2018 According to the Shire media release, committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the granting of marketing authorization in the European Union for VEYVONDI, for the treatment of bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand disease, based on the data from this and other two trials (700243677 and 700244574).
    • 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).
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