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

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Mission Dermatology Center
RECRUITING
Rancho Santa Margarita
Stanford University
RECRUITING
Redwood City
Florida
Pediatric Skin Research
RECRUITING
Coral Gables
Contact Information
Primary
Brittani Agostini
bagostini@krystalbio.com
4125865830
Time Frame
Start Date: 2021-05-25
Estimated Completion Date: 2028-05-25
Participants
Target number of participants: 50
Sponsors
Leads: Krystal Biotech, Inc.

This content was sourced from clinicaltrials.gov