Long-Term Safety Follow-Up Study of Krystal Biotechs Gene Therapy Products Using HSV-1 Backbone

What this Trial Is About

This research aims to evaluate the long-term safety of gene therapy products developed by Krystal Biotech, Inc. These products share a common herpes simplex virus type 1 HSV-1 backbone and have been given to participants in previous studies. The study focuses on participants with conditions such as dystrophic epidermolysis bullosa, including its recessive and dominant forms, who have received at least one dose of the investigational gene therapy. The study is observational and involves annual follow-up visits for up to five years after the participants last visit in their previous treatment study. These follow-up visits are designed to monitor and identify any delayed adverse events and to better understand how long the gene therapy products persist in the body. No new treatments are given during this follow-up period. Participants will be asked to provide consent and will undergo yearly safety assessments to track serious adverse events over five years. The study collects data on the participants health and any side effects that may appear long after the initial gene therapy treatment. This long-term monitoring helps ensure ongoing safety and provides valuable information about the gene therapy products.

Long-Term Follow-up Protocol