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A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease. PIP decision numbers P/0091/2012 and P/0214/2015

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Trial Profile

A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed with Severe von Willebrand Disease. PIP decision numbers P/0091/2012 and P/0214/2015

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2024

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At a glance

  • Drugs Octocog alfa (Primary) ; Vonicog alfa (Primary)
  • Indications Von Willebrand disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BAX 111 rVWF in Pediatrics
  • Sponsors Baxalta; Shire; Takeda

    • Most Recent Events

    • 09 Nov 2023 Planned End Date changed from 31 Mar 2024 to 1 Jan 2025.
    • 09 Nov 2023 Planned primary completion date changed from 31 Mar 2024 to 1 Jan 2025.
    • 30 Jun 2023 Planned End Date changed from 31 Mar 2023 to 31 Mar 2024.

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