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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: 25 Apr 2022

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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

  • 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
  • 20 Jul 2021 According to a Takeda media release, results from this trial were presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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