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Gene Therapy

Cohort 1 for Right Ventricular Cardiomyopathy (RIDGE-1 Trial)

Phase 1

Recruiting

Research Sponsored by Tenaya Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

RIDGE-1 Trial Summary

"This trial will test a new gene therapy called TN-401 on adult patients with a specific heart condition. The study will focus on assessing the safety and early effectiveness of the treatment."

Who is the study for?

Adults with a specific heart condition called ARVC linked to PKP2 mutations can join this trial. They should have symptoms, a left ventricular ejection fraction of 50% or more, an implantable cardiac defibrillator for at least a year, and frequent premature ventricular contractions. Those in NYHA Functional Class I to III are eligible.Check my eligibility

What is being tested?

The study is testing TN-401 gene therapy's safety and initial effectiveness on adults with symptomatic ARVC due to PKP2 mutations. It's the first time humans are receiving this treatment.See study design

What are the potential side effects?

Since it's an early-stage trial for TN-401 gene therapy, specific side effects aren't listed yet but may include typical gene therapy-related reactions like immune responses or injection site discomfort.

RIDGE-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and severity of Adverse Events over the course of the study.

Number of Serious Adverse Events related to study drug.

Secondary outcome measures

To assess changes in daily PVC and NSVT counts

To assess frequency of ICD therapy administration

To assess frequency of sustained VT

RIDGE-1 Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment1 Intervention

Dose for Cohort 2 will be 6E13 vg/kg

Group II: Cohort 1Experimental Treatment1 Intervention

Dose for Cohort 1 will be 3E13 vg/kg

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tenaya TherapeuticsLead Sponsor

3 Previous Clinical Trials

415 Total Patients Enrolled

Mayo ClinicOTHER

3,220 Previous Clinical Trials

3,767,936 Total Patients Enrolled

Johns Hopkins UniversityOTHER

2,266 Previous Clinical Trials

14,837,482 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit for participants being considered in this research study?

"To be eligible for this research study, individuals must meet the age requirements of being at least 18 years old and no more than 65 years old."

Answered by AI

Has the first group of participants in this study been granted approval by the Food and Drug Administration?

"Our research team at Power rates the safety of Cohort 1 as a grade 1 on our scale from 1 to 3. This rating is assigned due to the early Phase 1 nature of the trial, signifying scarce data backing both safety and efficacy claims."

Answered by AI

Are there any available openings for patients to participate in this study?

"As per clinicaltrials.gov, this particular research endeavor is presently not seeking participants. Initially shared on 4/1/2024 and last revised on 2/14/2024, the study remains inactive for enrollment currently. Despite this, there are numerous other investigations actively inviting candidates to partake in a myriad of studies totaling at least 182 ongoing opportunities."

Answered by AI

Which individuals meet the criteria for inclusion in this medical study?

"This clinical trial aims to enroll 15 individuals aged between 18 and 65 who have right ventricular cardiomyopathy. Essential requirements include a PKP2 mutation that is pathogenic or likely pathogenic, diagnosis of Arrhythmogenic Right Ventricular Cardiomyopathy as per the revised Task Force Criteria from 2010, left ventricular ejection fraction equal to or greater than 50%, in possession of an operational implantable cardiac defibrillator with remote integration features for at least one year before enrollment, NYHA Functional Class I, II, or III designation, and experiencing frequent premature ventricular contractions (PVCs)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC

2024. "Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06228924.

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