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A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

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Trial Profile

A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2025

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At a glance

  • Drugs Vonicog alfa (Primary) ; Factor VIII; Octocog alfa
  • Indications Von Willebrand disease
  • Focus Therapeutic Use
  • Acronyms rVWF IN PROPHYLAXIS
  • Sponsors Baxalta; Shire; Takeda

Most Recent Events

  • 06 Sep 2025 According to a Takeda media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for VONVENDI This approval is based on data from three clinical trials a Phase 3 trial in adults with VWD (NCT02973087), a Phase 3 study in children with VWD (NCT02932618) and a Phase 3b continuation trial in adults and children with VWD (NCT03879135) as well as supportive real world data.
  • 19 Apr 2022 Results assessing efficacy and safety of Recombinant von Willebrand factor prophylaxis in adults with severe von Willebrand disease published in the Blood
  • 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

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