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
Phase of Trial: Phase III
Latest Information Update: 12 Dec 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; Shire
- 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.
- 02 Dec 2016 Topline results published in a Shire media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History