Taking people in Olaszország3. fázis
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
Key facts
- Where
- Genoa, Milan és Rome, OlaszországSee the 3 sites
- Phase
- 3. fázis
Where in Olaszország
- Giannina Gaslini Institute For Scientific Hospitalization And CareGenoa, OlaszországTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sarepta Therapeutics, Inc.
- Trial code
- NCT05967351EU 2023-505043-39-00
- Record updated
- 2026. február 6.
- Original description
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.Read full original descriptionShow less
A Phase 3, Multinational, Long-term Follow-up Study to Evaluate Safety and Efficacy in Subjects Who Have Previously Received SRP-9001 in a Clinical Study
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.
Inclusion: 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: Not applicable.