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NCT04227106 · ClinicalTrials.gov registry record · Phase 3
Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
A Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, sponsored by Abeona Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
- 2
- Study locations
NCT04227106 is a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa that has completed, run by Abeona Therapeutics. The registered enrollment target is 11 participants, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (42% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04227106, a Phase 3 study of Epidermolysis Bullosa and Recessive Dystrophic Epidermolysis Bullosa, has completed, sponsored by Abeona Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
Conditions Studied
Interventions
- BIOLOGICAL EB-101
Study Locations (2)
California
- Stanford University - Redwood City
Massachusetts
- University of Massachusetts Medical School - Worcester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-01-10 |
| Est. Completion | 2022-10-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04227106
The ClinicalTrials.gov registry entry for NCT04227106 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 19-participant average among 10 other Epidermolysis Bullosa trials with a reported enrollment target (42% lower). The listed sponsor is Abeona Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Epidermolysis Bullosa appearing as the primary indexed condition, and to 1 intervention - of which EB-101 is the first listed.
NCT04227106 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04227106 about?
NCT04227106 is a clinical study titled "Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)". The purpose of this trial is to evaluate safety and efficacy of surgical application of EB-101 (autologous, gene-corrected keratinocyte sheets) as a treatment of recessive dystrophic epidermolysis bullosa (RDEB).
What is the current status of trial NCT04227106?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2020-01-10. Estimated completion is 2022-10-18.
What conditions does trial NCT04227106 study?
This clinical trial studies the following conditions: Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT04227106?
The interventions under investigation include: EB-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04227106?
This trial is sponsored by Abeona Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04227106 being conducted?
This trial has 2 study locations across California, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.