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NCT04917874 · ClinicalTrials.gov registry record · Phase 3
A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa
A Phase 3 study, sponsored by Krystal Biotech.
- Completed
- Registry status
- Phase 3
- Development phase
- 47
- Enrollment target
NCT04917874 is a Phase 3 study that has completed, run by Krystal Biotech. The registered enrollment target is 47 participants.
The verdict
NCT04917874, a Phase 3 study, has completed, sponsored by Krystal Biotech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 47 participants
- Enrollment target
Study Summary
This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoint will be to assess long term safety and tolerability of the topical gene therapy. The study is for those who participated in Phase 3 study, as well as, new participants who were unable to participate in the Phase 3 study, who meet all enrollment criteria.
Interventions
- BIOLOGICAL Open Label Topical Beremagene Geperpavec (B-VEC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2023-07-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04917874
The ClinicalTrials.gov registry entry for NCT04917874 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Krystal Biotech, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Open Label Topical Beremagene Geperpavec (B-VEC) is the first listed.
NCT04917874 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04917874 about?
NCT04917874 is a clinical study titled "A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa". This is a 112-week (approximately two-year) open-label extension study of Beremagene Geperpavec (B-VEC), for participants aged 2 months and older, who have been diagnosed with Dystrophic Epidermolysis Bullosa (DEB). Participants will be dosed weekly with the topical B-VEC therapy. The primary endpoi...
What is the current status of trial NCT04917874?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 47 participants. The study started on 2021-05-25. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT04917874?
The interventions under investigation include: Open Label Topical Beremagene Geperpavec (B-VEC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04917874?
This trial is sponsored by Krystal Biotech, which has 13 total clinical trials registered on ClinicalTrials.gov.
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