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Study to Evaluate the Safety and Effectiveness of ELEVIDYS in Participants With Duchenne Muscular Dystrophy Treated in a Post-Marketing Setting

NCT07542314 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ELEVIDYS

Administered via an intravenous infusion.

DRUG

Sirolimus

Administered orally.

DRUG

Glucocorticoids

Administered orally.

DRUG

Antibiotics

Administered orally.

Sponsors & Collaborators

  • Sarepta Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542314 on ClinicalTrials.gov