At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 145 enrolled
Drug / intervention
NexoBrid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating NexoBrid and Standard of Care for Thermal Burns. Completed, enrolled 145 participants across 36 sites in 14 countries.
Detailed Summary
This study will be a two-arms study intending to demonstrate superiority of NexoBrid treatment over SOC in children with thermal burns. The study objective is to evaluate the safety and clinical benefit of NexoBrid in hospitalized children (0-17 years) with deep partial and/or full thickness thermal burns of 1-30% TBSA and to compare NexoBrid to standard of care (SOC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThermal Burns
CountriesBelgium, Georgia, Germany, Hungary, India, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartMay 2015
Primary CompletionApr 2021
Study CompletionDec 2022
TodayJul 2026
First PostedOct 30, 2014
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2021
Study CompletionDec 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 11.7 years ago
Interventions
NexoBriddrug
NexoBrid is an enzymatic debriding agent for Eschar Removal.
Standard of Careprocedure
Surgical or Non-Surgical methods for Eschar Removal