A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care

Trial Profile

A Multicenter, Multinational, Randomized, Controlled, Assessor Blinded Study, Performed in Subjects With Thermal Burns, to Evaluate the Efficacy and Safety of NexoBrid Compared to Gel Vehicle and Compared to Standard of Care

Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Feb 2017

At a glance

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

    • 09 Feb 2017 According to a MediWound media release, data from phase II (PK) study and PK data in large burns obtained from the ongoing DETECT study will intend to support a request to FDA and EMA to extend the label for NexoBrid (Bromelains) to larger burns.
    • 14 Nov 2016 According to a MediWound media release, the acute top-line data is expected in the first half of 2018.
    • 14 Nov 2016 According to a MediWound media release, the trial protocol has been amended to increase the Total Body Surface Area (TBSA) of burn patients eligible for the study from 15% to 30%.
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