Status:
ENROLLING_BY_INVITATION
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
Lead Sponsor:
Sarepta Therapeutics, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previ...
Eligibility Criteria
Inclusion
- Received delandistrogene moxeparvovec for Duchenne muscular dystrophy in a previous clinical study.
- Has (a) parent(s) or legal caregiver(s) or is ≥18 years of age and able to understand and comply with the study visit schedule and all other protocol requirements.
Exclusion
- Participant or family does not want to disclose participation with general practitioner/primary care physician and other medical providers.
- Other inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2030
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05967351
Start Date
September 27 2023
End Date
November 30 2030
Last Update
January 17 2025
Active Locations (37)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
Lucile Packard Children's Hospital Stanford (LPCH)
Palo Alto, California, United States, 94304
4
University of California, Davis
Sacramento, California, United States, 95817