Status:
COMPLETED
A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa
Lead Sponsor:
Krystal Biotech, Inc.
Conditions:
Dystrophic Epidermolysis Bullosa
DEB - Dystrophic Epidermolysis Bullosa
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Willing and able to give consent/assent
- Clinical diagnosis of epidermolysis bullosa
- Confirmation of diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
- Age: 2 months of age and older at the time of informed consent/assent
- Women of childbearing age must be willing to use reliable birth control method throughout the treatment duration and for 3 months following the last treatment application
Exclusion
- Diseases or conditions that could interfere with the assessment of safety of the study treatment and compliance of the participant with study visits/procedures, as determined by the Investigator
- Pregnant or nursing women
- Active infection in the area that will undergo administration, that the Investigator believes will negatively impact the IP application
- Known allergy to any of the constituents of the product
- Concurrent skin transplant or mesh skin grafting; if the participant is currently having transplantation or grafting surgeries they must wait until the transplant has begun to heal and the graft has absorbed prior to initiating B-VEC therapy
- Participation in an interventional gene therapy clinical trial within the past three (3) months (not including B-VEC administration)
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT04917874
Start Date
May 25 2021
End Date
July 31 2023
Last Update
April 9 2024
Active Locations (6)
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1
Mission Dermatology Center
Rancho Santa Margarita, California, United States, 92688
2
Stanford University
Redwood City, California, United States, 94063
3
Pediatric Skin Research
Coral Gables, Florida, United States, 33146
4
Northwestern University
Chicago, Illinois, United States, 60611