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NCT03293524 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year
A Phase 3 study, sponsored by GenSight Biologics.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT03293524 is a Phase 3 study that has completed, run by GenSight Biologics. The registered enrollment target is 98 participants.
The verdict
NCT03293524, a Phase 3 study, has completed, sponsored by GenSight Biologics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to assess the efficacy and safety of GS010 gene therapy - (lenadogene nolparvovec) in subjects with LHON due to the G11778A ND4 mitochondrial mutation with a vision loss up to one year.
Interventions
- DRUG Placebo
- GENETIC GS010
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2018-03-12 |
| Est. Completion | 2024-07-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03293524
The ClinicalTrials.gov registry entry for NCT03293524 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GenSight Biologics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03293524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03293524 about?
NCT03293524 is a clinical study titled "Efficacy & Safety Study of Bilateral IVT Injection of GS010 in LHON Subjects Due to the ND4 Mutation for up to 1 Year". The goal of this clinical trial is to assess the efficacy and safety of GS010 gene therapy - (lenadogene nolparvovec) in subjects with LHON due to the G11778A ND4 mitochondrial mutation with a vision loss up to one year.
What is the current status of trial NCT03293524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2018-03-12. Estimated completion is 2024-07-23.
What interventions are being tested in trial NCT03293524?
The interventions under investigation include: Placebo (DRUG), GS010 (GENETIC).
Who is sponsoring clinical trial NCT03293524?
This trial is sponsored by GenSight Biologics, which has 6 total clinical trials registered on ClinicalTrials.gov.
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