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NCT04491604 · ClinicalTrials.gov registry record · Phase 3
Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB
A Phase 3 study, sponsored by Krystal Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
NCT04491604: Completed Phase 3 study, sponsored by Krystal Biotech.
NCT04491604 is a Phase 3 study that has completed, run by Krystal Biotech. The registered enrollment target is 31 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04491604, a Phase 3 study, has completed, sponsored by Krystal Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
Study Summary
To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
Primary Outcome
The primary wound was defined as a responder wound that met either of the following conditions: * Complete wound healing on Week 22 and Week 24, or * Complete wound healing on Week 24 and Week 26. For subjects with missing primary wound healing data, a multiple imputation approach (10 repliates) was used. The total numbers of primary wounds with complete healing for B-VEC and Placebo presented below were the average of those from the multiple imputation replicates, and therefore, they would no
Interventions
- OTHER Placebo
- BIOLOGICAL Topical Beremagene Geperpavec
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-08-17 |
| Est. Completion | 2022-01-14 |
| Phase | Phase 3 |
What the finished NCT04491604 record still lists
NCT04491604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04491604 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04491604 about?
NCT04491604 is a clinical study titled "Ph 3 Efficacy and Safety of B-VEC for the Treatment of DEB". To determine whether administration of topical B-VEC improves wound healing as compared to placebo, and to evaluate durability, repeat dosing (Primary Endpoint) and further obtain safety and tolerability data.
What is the current status of trial NCT04491604?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2020-08-17. Estimated completion is 2022-01-14.
What interventions are being tested in trial NCT04491604?
The interventions under investigation include: Placebo (OTHER), Topical Beremagene Geperpavec (BIOLOGICAL).
Who is sponsoring clinical trial NCT04491604?
This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04491604's enrollment target sits among peer trials
31 1914th of 2000 higher than 84 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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