Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex (rVWF:rFVIII): A Phase 1 Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability in Type 3 Von Willebrand Disease (VWD)
Phase of Trial: Phase I
Latest Information Update: 02 Jul 2018
At a glance
- Drugs Factor VIII/von Willebrand factor (Primary)
- Indications Von Willebrand disease
- Focus Adverse reactions
- Sponsors Baxter Healthcare Corporation
- 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 700251088).
- 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.
- 08 Dec 2015 Results of pooled analysis from this and other phase III trial (n=56), presented at the 57th Annual Meeting and Exposition of the American Society of Hematology.