RECRUITING

Long-Term Follow-up Protocol

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-05-25
Study Completion:2028-05-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04917887

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Consent/Assent must be obtained by the participants (and, parental/legal representative, when applicable) prior to any study-related data being collected.
  3. * Participant is willing and able to adhere to the protocol requirements.
  1. * Participants who enroll into a non-Krystal Biotech, Inc. interventional gene therapy clinical trial will be excluded from the study.

Contacts and Locations

Study Contact

Brittani Agostini
CONTACT
4125865830
bagostini@krystalbio.com

Study Locations (Sites)

Mission Dermatology Center
Rancho Santa Margarita, California, 92688
United States
Stanford University
Redwood City, California, 94063
United States
Pediatric Skin Research
Coral Gables, Florida, 33146
United States

Collaborators and Investigators

Sponsor: Krystal Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-25
Study Completion Date2028-05-25

Study Record Updates

Study Start Date2021-05-25
Study Completion Date2028-05-25

Terms related to this study

Additional Relevant MeSH Terms

  • Dystrophic Epidermolysis Bullosa
  • Recessive Dystrophic Epidermolysis Bullosa
  • Dominant Dystrophic Epidermolysis Bullosa