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A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

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Trial Profile

A Phase 3 Clinical Study to Determine the Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor : Recombinant Factor VIII (rVWF:rFVIII) and rVWF in the Treatment of Bleeding Episodes in Subjects Diagnosed With Von Willebrand Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 02 Feb 2022

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At a glance

  • Drugs Vonicog alfa (Primary) ; Octocog alfa
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxalta; Baxter Healthcare Corporation; Baxter Innovations GmbH

Most Recent Events

  • 31 Jan 2022 According to a Takeda media release, the U.S. Food & Drug Administration (FDA) approved VONVENDI for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease (VWD) receiving on-demand therapy.
  • 14 Dec 2021 Data from four studies ((NCT00816660; NCT01410227; NCT02283268; NCT02973087) used to the exposure-response (ER) relationship between VWF activity (measured by VWF:ristocetin cofactor [RCo]), endogenous factor VIII (FVIII) activity (measured by FVIII:C), and spontaneous bleeding events (sBEs) in patients with severe VWD receiving rVWF prophylaxis for up to 1 year presented at the 63rd American Society of Hematology Annual Meeting and Exposition
  • 14 Jun 2021 According to a Takeda media release, the results of this phase 3 study will be presented at the International Society of Thrombosis and Haemostasis (ISTH) Congress on 20th Jul 2021.

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