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NCT02148705 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns
A Phase 3 study, sponsored by MediWound.
- Completed
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT02148705 is a Phase 3 study that has completed, run by MediWound. The registered enrollment target is 175 participants.
The verdict
NCT02148705, a Phase 3 study, has completed, sponsored by MediWound.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle, 2. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients' surgical burden and its related blood loss as compared to SOC, 3. To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long term outcomes of cosmesis and function.
Interventions
- PROCEDURE Standard of Care (SOC)
- DRUG Gel Vehicle
- DRUG NexoBrid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2015-05-27 |
| Est. Completion | 2020-08-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02148705
The ClinicalTrials.gov registry entry for NCT02148705 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediWound, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard of Care (SOC) is the first listed.
NCT02148705 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02148705 about?
NCT02148705 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns". This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are: 1. To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing com...
What is the current status of trial NCT02148705?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2015-05-27. Estimated completion is 2020-08-20.
What interventions are being tested in trial NCT02148705?
The interventions under investigation include: Standard of Care (SOC) (PROCEDURE), Gel Vehicle (DRUG), NexoBrid (DRUG).
Who is sponsoring clinical trial NCT02148705?
This trial is sponsored by MediWound, which has 7 total clinical trials registered on ClinicalTrials.gov.
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