A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study

Sarepta Therapeutics, Inc.

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 previous clinical study. No study drug will be administered as part of this study.

Eligibility

Age range: Not specified
Sex: Male
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * 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 Criteria: * Not applicable

Interventions

Genetic
delandistrogene moxeparvovec
No study drug will be administered as part of this study. Eligible participants who received treatment with delandistrogene moxeparvovec during a previous clinical study will be included.

Locations (38)

Arkansas Children's Hospital
Little Rock, Arkansas
UCLA Medical Center
Los Angeles, California
Lucile Packard Children's Hospital Stanford (LPCH)
Palo Alto, California
University of California, Davis
Sacramento, California
Rady Children's Hospital
San Diego, California
Children's Hospital of Colorado
Aurora, Colorado