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NCT06228924 · ClinicalTrials.gov registry record · Phase 1
Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC
A Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by Tenaya Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 7
- Study locations
NCT06228924: Recruiting Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy, sponsored by Tenaya Therapeutics.
NCT06228924 is a Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy that is actively recruiting participants, run by Tenaya Therapeutics. The registered enrollment target is 15 participants, below the 381-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06228924, a Phase 1 study of Arrhythmogenic Right Ventricular Cardiomyopathy, is actively recruiting participants, sponsored by Tenaya Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 7
- Study locations
Study Summary
This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
Conditions Studied
Interventions
- GENETIC TN-401
Study Locations (7)
California
- University of California San Francisco - San Francisco
Colorado
- University of Colorado - Anschutz Medical Campus - Aurora
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- NYU Langone Health - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2029-10-01 |
| Phase | Phase 1 |
What NCT06228924 shows while recruiting
NCT06228924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 381-participant average among 4 other Arrhythmogenic Right Ventricular Cardiomyopathy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Arrhythmogenic Right Ventricular Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which TN-401 is the first listed.
NCT06228924 lists 7 locations in 7 states (California, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT06228924 about?
NCT06228924 is a clinical study titled "Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC". This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.
What is the current status of trial NCT06228924?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2024-03-26. Estimated completion is 2029-10-01.
What conditions does trial NCT06228924 study?
This clinical trial studies the following conditions: Arrhythmogenic Right Ventricular Cardiomyopathy.
What interventions are being tested in trial NCT06228924?
The interventions under investigation include: TN-401 (GENETIC).
Who is sponsoring clinical trial NCT06228924?
This trial is sponsored by Tenaya Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06228924 being conducted?
This trial has 7 study locations across California, Colorado, Maryland, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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