Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02161380 · ClinicalTrials.gov registry record · Phase 1
Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy
A Phase 1 study, sponsored by Byron Lam.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT02161380 is a Phase 1 study that has completed, run by Byron Lam. The registered enrollment target is 28 participants.
The verdict
NCT02161380, a Phase 1 study, has completed, sponsored by Byron Lam.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The study is a dose-escalation study, phase 1. The objective of this proposed clinical trial is to evaluate the safety of mitochondrially targeted ND4 gene therapy with the adeno-associated viral vector in appropriate LHON patients.
Interventions
- DRUG injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low),
- DRUG injection of scAAV2-P1ND4v2 5.81 X10e9 vg (Med)
- DRUG injection of scAAV2-P1ND4v2 2.4 X10e10vg (High)
- DRUG injection of scAAV2-P1ND4v2 1.0 X10e11vg (Higher)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-07-14 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02161380
The ClinicalTrials.gov registry entry for NCT02161380 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Byron Lam, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low), is the first listed.
NCT02161380 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02161380 about?
NCT02161380 is a clinical study titled "Safety Study of an Adeno-associated Virus Vector for Gene Therapy of Leber's Hereditary Optic Neuropathy". The study is a dose-escalation study, phase 1. The objective of this proposed clinical trial is to evaluate the safety of mitochondrially targeted ND4 gene therapy with the adeno-associated viral vector in appropriate LHON patients.
What is the current status of trial NCT02161380?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2014-07-14. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT02161380?
The interventions under investigation include: injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low), (DRUG), injection of scAAV2-P1ND4v2 5.81 X10e9 vg (Med) (DRUG), injection of scAAV2-P1ND4v2 2.4 X10e10vg (High) (DRUG), injection of scAAV2-P1ND4v2 1.0 X10e11vg (Higher) (DRUG).
Who is sponsoring clinical trial NCT02161380?
This trial is sponsored by Byron Lam, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.