A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study (EXPEDITION)
Status and phase
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Details and patient eligibility
About
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.
Enrollment
Sex
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
400 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Sarepta Therapeutics Inc. For Clinical Trial Information, Select Option 4
Data sourced from clinicaltrials.gov
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