Phase 4Recruiting
Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting (ENHANCE)
Phase 4 Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Patients With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting (ENHANCE)
- Sponsor
- Sarepta Therapeutics, Inc. (Industry)
- Enrolment
- 20 planned
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- ELEVIDYS; Sirolimus; Glucocorticoids; Antibiotics
- Ages
- children, adults, older adults
- Registry
- NCT07542314
Full record on ClinicalTrials.gov
From the registry
The primary objective of this study is to evaluate acute liver injury (ALI) rates associated with ELEVIDYS with the addition of sirolimus as an adjunct prophylactic immunosuppression agent.
Primary outcomes
- Cohort 1: Number of Participants with ALI
History
Primary completion expected
Expected to start
Last registry update
Registered