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Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures

Trial Profile

Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2017

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At a glance

  • Drugs Factor VIII/von Willebrand factor (Primary)
  • Indications Surgical blood loss; Von Willebrand disease
  • Focus Therapeutic Use
  • Acronyms WONDERS
  • Sponsors Octapharma
  • Most Recent Events

    • 17 Apr 2017 Status changed from recruiting to discontinued, as the trial met its primary endpoint at the pre-specified interim analysis after 30 surgical procedures, according to the results published in the Haemophilia
    • 01 Mar 2017 Primary endpoint (Overall hemostatic efficacy (success or failure) of wilate, based on the intra-operative assessment of the surgeon and the post-operative assessment by the investigator using a 4-point ordinal efficacy scale) has been met, according to the results published in the Haemophilia
    • 01 Mar 2017 Results published in the Haemophilia
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