Status:
RECRUITING
Long-Term Follow-up Protocol
Lead Sponsor:
Krystal Biotech, Inc.
Conditions:
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Eligibility:
All Genders
6+ years
Brief Summary
The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. whic...
Detailed Description
Due to the guidelines for gene therapy for vectors which may undergo latency/ reactivation, Krystal Biotech, Inc. has established a Long-Term Follow-up Protocol which will identify and mitigate the lo...
Eligibility Criteria
Inclusion
- All adult and pediatric participants who received at least one gene therapy treatment in a previous Krystal Biotech, Inc. sponsored study, and have discontinued or completed the parent treatment protocol (which do not have the LTFU embedded into the parent protocol), as applicable.
- Consent/Assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected.
- Participant is willing and able to adhere to the protocol requirements.
Exclusion
- Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 25 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04917887
Start Date
May 25 2021
End Date
May 25 2028
Last Update
June 8 2021
Active Locations (3)
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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