A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study

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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 previous clinical study. No study drug will be administered as part of this study. Pre-infusion baseline will be defined as the timepoint just prior to infusion of delandistrogene moxeparvovec from a previous clinical study. Each participant will be followed for a minimum of 5 years post-infusion of delandistrogene moxeparvovec from a previous clinical study. The duration of participation in this study is dependent on the length of follow-up the participant completed post-infusion of delandistrogene moxeparvovec from a previous clinical study.

Primary Purpose

Other

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

N/A

Maximum Age

N/A

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:

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.

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Enrolling by Invitation

These studies are not open to everyone who meets the eligibility criteria, but only to people in that particular population, who are specifically invited to participate.

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Study Stats

Protocol No.

23-000873