[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533677":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":34,"responsibleParty":129,"collaborators":24,"id":131,"slug":24,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":24,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"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",[35,51,64,78,91,104,116],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of California San Francisco","RECRUITING","San Francisco","California","94143","United States",{"type":43,"coordinates":44},"Point",[45,46],-122.41942,37.77493,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":24,"phoneExt":24,"email":24},"Vasanth Vedantham, MD",{"facility":52,"status":37,"city":53,"state":54,"zip":55,"country":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"University of Colorado - Anschutz Medical Campus","Aurora","Colorado","80045",{"type":43,"coordinates":57},[58,59],-104.83192,39.72943,{"lat":59,"lon":58},[62],{"name":63,"role":28,"phone":24,"phoneExt":24,"email":24},"Matthew Taylor, MD",{"facility":65,"status":37,"city":66,"state":67,"zip":68,"country":41,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Johns Hopkins University","Baltimore","Maryland","21287",{"type":43,"coordinates":70},[71,72],-76.61219,39.29038,{"lat":72,"lon":71},[75],{"name":76,"role":77,"phone":24,"phoneExt":24,"email":24},"Andreas Barth, MD","PRINCIPAL_INVESTIGATOR",{"facility":79,"status":37,"city":80,"state":81,"zip":82,"country":41,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Brigham and Women's Hospital","Boston","Massachusetts","02115",{"type":43,"coordinates":84},[85,86],-71.05977,42.35843,{"lat":86,"lon":85},[89],{"name":90,"role":28,"phone":24,"phoneExt":24,"email":24},"Neal Lakdawala, MD",{"facility":92,"status":37,"city":93,"state":94,"zip":95,"country":41,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Mayo Clinic","Rochester","Minnesota","55905",{"type":43,"coordinates":97},[98,99],-92.4699,44.02163,{"lat":99,"lon":98},[102],{"name":103,"role":77,"phone":24,"phoneExt":24,"email":24},"John R. Giudicessi, MD",{"facility":105,"status":37,"city":106,"state":106,"zip":107,"country":41,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"NYU Langone Health","New York","10016",{"type":43,"coordinates":109},[110,111],-74.00597,40.71427,{"lat":111,"lon":110},[114],{"name":115,"role":28,"phone":24,"phoneExt":24,"email":24},"Larry Chinitz, MD",{"facility":117,"status":37,"city":118,"state":119,"zip":120,"country":41,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":43,"coordinates":122},[123,124],-81.69541,41.4995,{"lat":124,"lon":123},[127],{"name":128,"role":28,"phone":24,"phoneExt":24,"email":24},"Milind Desai, MD",{"type":130,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","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":142,"type":143},15,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149],"Arrhythmogenic Right Ventricular Cardiomyopathy",[151,152,153,154,155,156,157,158,159,160],"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":163,"type":164},"2025-02-06","ACTUAL",{"date":166,"type":164},"2024-03-26",{"date":168,"type":143},"2029-10-01",{"name":5,"class":6},7]