Long-Term Follow-up Protocol

Part of paid clinical trials in Rancho Santa Margarita, California.

Sponsor
Krystal Biotech, Inc.
Study ID
NCT04917887
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Months - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
May 25, 2021
Status verified
Jun 2021
Primary completion
May 25, 2028
Completion
May 25, 2028

Study Design

Enrollment
50 participants (estimated)

Primary Outcome Measure

Serious Adverse Events (AE) [ Time Frame: 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mission Dermatology CenterRancho Santa MargaritaCalifornia92688
Guida Pinto
[email protected]
949-858-3376
Shireen Guide, MD (PRINCIPAL_INVESTIGATOR)
Stanford UniversityRedwood CityCalifornia94063
Sinem Bagci
[email protected]
650-484-6878
Peter Marinkovich, MD (PRINCIPAL_INVESTIGATOR)
Pediatric Skin ResearchCoral GablesFlorida33146
Edilmary Urdaneta
Mercedes Gonzalez, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rancho Santa Margarita, CA

By research site
Mission Dermatology Center· Rancho Santa Margarita, CAStanford University· Redwood City, CAPediatric Skin Research· Coral Gables, FL

Related Studies