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Taking people in United StatesNo phase

Long-Term Follow-up Protocol

Key facts

Who runs it
Krystal Biotech, Inc.
Where
Coral Gables, Rancho Santa Margarita, and Redwood City, United StatesSee the 3 sites
Trial code
Status
Recruiting
People taking part
50 people, planned
Started
25 May 2021
Expected to end
25 May 2028
Type of study
Observational
Record updated
8 June 2021

Who can take part

Age
6 months and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in United States

  • Pediatric Skin ResearchCoral Gables, United StatesContact: Edilmary UrdanetaTaking people
  • Mission Dermatology CenterRancho Santa Margarita, United StatesContact: Guida PintoTaking people
  • Stanford UniversityRedwood City, United StatesContact: Sinem BagciTaking people

About the trial

What the trial wants to find out

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
8 June 2021