A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
NCT05967351 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2026-02-06
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.
Conditions
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.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Sarepta Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-27
- Primary Completion
- 2033-10-31
- Completion
- 2033-10-31
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Germany
- Hong Kong
- Italy
- Japan
- Spain
- Taiwan
- United Kingdom
Study Locations
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