[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533677":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":34,"responsibleParty":130,"collaborators":24,"id":132,"slug":133,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":134,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":24,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Tenaya Therapeutics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Dose for Cohort 1 will be 3E13 vg\u002Fkg",[13],"Genetic: TN-401",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Dose for Cohort 2 will be 6E13 vg\u002Fkg",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"GENETIC","TN-401","TN-401 is a recombinant adeno-associated virus serotype 9 (AAV9) gene therapy containing Plakophilin-2 (PKP2) transgene. It is a single (one-time) intravenous dose.",[9,15],null,[26,31],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Matthew Pollman, M.D.","CONTACT","(650) 416-1186","mpollman@tenayathera.com",{"name":32,"role":28,"phone":24,"phoneExt":24,"email":33},"Niha Kamat","clinical.trials@tenayathera.com",[35,52,65,79,92,105,117],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of California San Francisco","RECRUITING","San Francisco","California","94143","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-122.41942,37.77493,{"lat":47,"lon":46},[50],{"name":51,"role":28,"phone":24,"phoneExt":24,"email":24},"Vasanth Vedantham, MD",{"facility":53,"status":37,"city":54,"state":55,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Colorado - Anschutz Medical Campus","Aurora","Colorado","80045",{"type":44,"coordinates":58},[59,60],-104.83192,39.72943,{"lat":60,"lon":59},[63],{"name":64,"role":28,"phone":24,"phoneExt":24,"email":24},"Matthew Taylor, MD",{"facility":66,"status":37,"city":67,"state":68,"zip":69,"country":41,"countryCode":42,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Johns Hopkins University","Baltimore","Maryland","21287",{"type":44,"coordinates":71},[72,73],-76.61219,39.29038,{"lat":73,"lon":72},[76],{"name":77,"role":78,"phone":24,"phoneExt":24,"email":24},"Andreas Barth, MD","PRINCIPAL_INVESTIGATOR",{"facility":80,"status":37,"city":81,"state":82,"zip":83,"country":41,"countryCode":42,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"type":44,"coordinates":85},[86,87],-71.05977,42.35843,{"lat":87,"lon":86},[90],{"name":91,"role":28,"phone":24,"phoneExt":24,"email":24},"Neal Lakdawala, MD",{"facility":93,"status":37,"city":94,"state":95,"zip":96,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Mayo Clinic","Rochester","Minnesota","55905",{"type":44,"coordinates":98},[99,100],-92.4699,44.02163,{"lat":100,"lon":99},[103],{"name":104,"role":78,"phone":24,"phoneExt":24,"email":24},"John R. Giudicessi, MD",{"facility":106,"status":37,"city":107,"state":107,"zip":108,"country":41,"countryCode":42,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"NYU Langone Health","New York","10016",{"type":44,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},[115],{"name":116,"role":28,"phone":24,"phoneExt":24,"email":24},"Larry Chinitz, MD",{"facility":118,"status":37,"city":119,"state":120,"zip":121,"country":41,"countryCode":42,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":44,"coordinates":123},[124,125],-81.69541,41.4995,{"lat":125,"lon":124},[128],{"name":129,"role":28,"phone":24,"phoneExt":24,"email":24},"Milind Desai, MD",{"type":131,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100533677","phase-1-open-label-dose-escalation-study-of-safety-and-preliminary-efficacy-of-tn-401-in-adults-with-pkp2-mutation-associated-arvc-100533677",false,"NCT06228924","Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC","First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults With PKP2 Mutation-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","RIDGE-1","Inclusion Criteria:\n\n* PKP2 mutation (pathogenic or likely pathogenic)\n* Arrhythmogenic Right Ventricular Cardiomyopathy as defined by the 2010 revised Task Force Criteria\n* Left Ventricular Ejection Fraction ≥50%\n* Functioning Implantable Cardiac Defibrillator with remote integration capabilities at least 9 months prior to Screening\n* NYHA Functional Class I, II, or III\n* Frequent premature ventricular contractions (PVCs)\n\nExclusion Criteria:\n\n* Ventricular tachycardia (VT) ablation within 6 months of Screening or planned VT ablation within 6 months after Screening\n* High AAV9 neutralizing antibody titer\n* Prior myocardial infarction\n* Right Ventricular Heart Failure\n* Class IV Heart Failure\n* Clinically significant renal disease\n* Clinically significant liver disease","ALL","18 Years","65 Years",{"count":144,"type":145},15,"ESTIMATED","INTERVENTIONAL",[148],"PHASE1","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.",[151],"Arrhythmogenic Right Ventricular Cardiomyopathy",[153,154,155,156,157,158,159,160,161,162],"PKP2 Mutation Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","Arrhythmogenic Cardiomyopathy (ACM)","PKP2-associated ARVC","PKP2-ARVC","PKP2-ACM","Adeno Associated Virus (AAV)","Gene Therapy","Gene Transfer","Genetic cardiomyopathy","Heart Failure","2025-02-05",{"date":165,"type":166},"2025-02-06","ACTUAL",{"date":168,"type":166},"2024-03-26",{"date":170,"type":145},"2029-10-01",{"name":5,"class":6},7]