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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)

Trial Profile

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)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Sep 2018

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At a glance

  • Drugs Factor VIII/von Willebrand factor (Primary)
  • Indications Von Willebrand disease
  • Focus Adverse reactions
  • Sponsors Baxter Healthcare Corporation
  • Most Recent Events

    • 12 Sep 2018 According to the Shire media release, based on the data from this and other two phase 3 trials (700243677 and 700251088), 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 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.
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