A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment

Trial Profile

A Multicenter, Multinational, Randomized, Controlled, Open Label Study, Performed in Children With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid as Compared to Standard of Care (SOC) Treatment

Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2017

At a glance

  • Drugs Bromelains (Primary)
  • Indications Burns
  • Focus Registrational; Therapeutic Use
  • Acronyms CIDS
  • Sponsors MediWound
  • Most Recent Events

    • 19 Jul 2017 According to a MediWound media release, the company has submitted the pediatric phase 3 protocol to the FDA with the goal of enrolling U.S. pediatric burn patients into the study.
    • 06 Feb 2017 According to a MediWound media release, the company has initiated second stage of tris trial which includes patients from age one to 18.
    • 06 Feb 2017 According to a MediWound media release, the European Medicines Agency has endorsed the extension of the population in this trial to include patients age one to 18. The extension is based on the recommendation of the Data Safety Monitoring Board (DSMB) for this trial after blindle reviewing the accumulated data in this study.
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