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Long-Term Follow-up Protocol
Recruiting
I'm InterestedTrial ID: NCT04917887
Purpose
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. which have a shared backbone of HSV-1, in participants who received at least
one dose of investigational product (IP).
Official Title
A Prospective, Observational, Long-Term Follow-Up (LTFU) Study to Evaluate the Long-Term Safety of the Krystal Biotech, Inc. Gene Therapy Backbone Products Using HSV-1 Backbone
Stanford Investigator(s)
M. Peter Marinkovich, MD
Associate Professor of Dermatology
Eligibility
Inclusion Criteria:
- 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 Criteria:
- Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy
clinical trial will be excluded from the study.
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sinem Bagci
650-484-6878