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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Apr 2018

At a glance

  • Drugs Rurioctocog alfa (Primary) ; Vonicog alfa (Primary)
  • Indications Von Willebrand disease
  • Focus Therapeutic Use
  • Sponsors Baxalta; Shire
  • Most Recent Events

    • 15 Feb 2018 Planned End Date changed from 1 Jul 2019 to 29 May 2020.
    • 15 Feb 2018 Planned primary completion date changed from 1 Jul 2019 to 29 May 2020.
    • 16 Jan 2018 Status changed from not yet recruiting to recruiting.
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