RecruitingNCT04917887

Long-Term Follow-up Protocol

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


Sponsor

Krystal Biotech, Inc.

Enrollment

50 participants

Start Date

May 25, 2021

Study Type

OBSERVATIONAL

Conditions

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. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP).


Eligibility

Min Age: 6 Months

Plain Language Summary

Simplified for easier understanding

This is a long-term follow-up study for people who previously received a gene therapy made by Krystal Biotech, Inc. in an earlier clinical trial. The study monitors participants for years after their gene therapy treatment to track long-term safety and any delayed effects. You may be eligible if: - You previously received at least one dose of a Krystal Biotech gene therapy in an earlier study - You have completed or discontinued the original parent study - You are willing and able to follow the protocol requirements - You (or your parent/guardian if a minor) have provided informed consent You may NOT be eligible if: - You enroll in a gene therapy trial from a different (non-Krystal Biotech) company during this follow-up period Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Mission Dermatology Center

Rancho Santa Margarita, California, United States

Stanford University

Redwood City, California, United States

Pediatric Skin Research

Coral Gables, Florida, United States

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NCT04917887


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