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NCT03536143 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients
A Phase 1 study of Dystrophic Epidermolysis Bullosa, sponsored by Krystal Biotech.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03536143: Completed Phase 1 study of Dystrophic Epidermolysis Bullosa, sponsored by Krystal Biotech.
NCT03536143 is a Phase 1 study of Dystrophic Epidermolysis Bullosa that has completed, run by Krystal Biotech. The registered enrollment target is 12 participants, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03536143, a Phase 1 study of Dystrophic Epidermolysis Bullosa, has completed, sponsored by Krystal Biotech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study was conducted to assess the safety and efficacy of topical Beremagene Geperpavec (KB103, HSV1-COL7) on DEB patients.
Primary Outcome
Safety assessments included evaluation of medical and medication history, physical / skin examination, vital signs, adverse events, and laboratory evaluations. Due to the 'split-person' intrasubject design, the safety assessments were reported at subject level, but not per intervention.
Conditions Studied
Interventions
- BIOLOGICAL Topical beremagene geperpavec
- BIOLOGICAL Placebo gel
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-05-06 |
| Est. Completion | 2019-11-01 |
| Phase | Phase 1 |
What the finished NCT03536143 record still lists
NCT03536143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 19-participant average among 7 other Dystrophic Epidermolysis Bullosa trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Dystrophic Epidermolysis Bullosa appearing as the primary indexed condition, and to 2 interventions - of which Topical beremagene geperpavec is the first listed.
NCT03536143 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03536143 about?
NCT03536143 is a clinical study titled "A Phase I/II Study of KB103, a Topical HSV1-COL7, on DEB Patients". This study was conducted to assess the safety and efficacy of topical Beremagene Geperpavec (KB103, HSV1-COL7) on DEB patients.
What is the current status of trial NCT03536143?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-05-06. Estimated completion is 2019-11-01.
What conditions does trial NCT03536143 study?
This clinical trial studies the following conditions: Dystrophic Epidermolysis Bullosa.
What interventions are being tested in trial NCT03536143?
The interventions under investigation include: Topical beremagene geperpavec (BIOLOGICAL), Placebo gel (BIOLOGICAL).
Who is sponsoring clinical trial NCT03536143?
This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03536143 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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