Long-Term Follow-up Protocol

Recruiting now

Conditions studied: Dystrophic Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa, Dominant Dystrophic Epidermolysis Bullosa

In brief

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).

Key facts

Study ID

NCT04917887

Run by

Krystal Biotech, Inc.

People needed

50

Starts

2021-05-25

Expected to finish

2028-05-25

Last updated by the study team

2021-06-08

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.

Where it is running

• Mission Dermatology Center — Rancho Santa Margarita, California, United States (enrolling)
• Stanford University — Redwood City, California, United States (enrolling)
• Pediatric Skin Research — Coral Gables, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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