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NCT06597656 · ClinicalTrials.gov registry record · Phase 1
A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74
A Phase 1 study, sponsored by Sarepta Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT06597656: Clinical Trial Phase 1 study, sponsored by Sarepta Therapeutics.
NCT06597656 is a Phase 1 study that was terminated before completion, run by Sarepta Therapeutics. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597656, a Phase 1 study, was terminated before completion, sponsored by Sarepta Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is a gene transfer therapy study evaluating the safety of and delandistrogene moxeparvovec dystrophin protein expression from delandistrogene moxeparvovec following therapeutic plasma exchange (plasmapheresis) in ambulatory male participants with DMD and pre-existing antibodies to AAVrh74 over a period of 59 weeks.
Interventions
- GENETIC delandistrogene moxeparvovec
- PROCEDURE Plasmapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-09-18 |
| Est. Completion | 2025-08-05 |
| Phase | Phase 1 |
Why NCT06597656 stopped before completion
NCT06597656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which delandistrogene moxeparvovec is the first listed.
NCT06597656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06597656 about?
NCT06597656 is a clinical study titled "A Gene Transfer Therapy to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Therapeutic Plasma Exchange (Plasmapheresis) in Participants With Duchenne Muscular Dystrophy (DMD) and Pre-existing Antibodies to AAVrh74". This is a gene transfer therapy study evaluating the safety of and delandistrogene moxeparvovec dystrophin protein expression from delandistrogene moxeparvovec following therapeutic plasma exchange (plasmapheresis) in ambulatory male participants with DMD and pre-existing antibodies to AAVrh74 over ...
What is the current status of trial NCT06597656?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2024-09-18. Estimated completion is 2025-08-05.
What interventions are being tested in trial NCT06597656?
The interventions under investigation include: delandistrogene moxeparvovec (GENETIC), Plasmapheresis (PROCEDURE).
Who is sponsoring clinical trial NCT06597656?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06597656's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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