[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07050160":3,"trial-entities:NCT07050160":80,"trial-summary:NCT07050160":84},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":38,"primary_purpose":15,"phases":39,"enrollment_info":40,"interventions":43,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":60,"locations":63,"central_contacts":73,"overall_officials":74,"references":78,"see_also_links":79},"NCT07050160","LX2020-02","Long-term Follow-up Study of Gene Therapy for Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant","A Phase 1\u002F2 Long-term Follow-up Study of the Safety and Efficacy of LX2020 Gene Therapy in Patients With Arrhythmogenic Cardiomyopathy Due to a Plakophilin-2 Pathogenic Variant","ENROLLING_BY_INVITATION","2030-08","2025-11","2025-11-12","2025-08-29","Lexeo Therapeutics","INDUSTRY",null,"The primary objective of this Phase 1\u002F2 long-term follow-up (LTFU) study is to assess the long-term safety and tolerability of LX2020 for the treatment of arrhythmogenic cardiomyopathy (ACM) due to a plakophilin-2 gene (PKP2) pathogenic variant (PKP2-ACM).","GRIT-PKP2 is a Phase 1\u002F2 long-term follow-up (LTFU) study designed to evaluate the long-term safety and tolerability of LX2020 gene therapy for participants with PKP2-ACM who have previously received LX2020 in the parent study, LX2020-01. After completion of Study LX2020-01, participants will roll over into this study LX2020-02 for an additional 4-year long-term observation. No gene therapy will be administered in Study LX2020-02. Efficacy will be assessed as an exploratory objective.",[19,20,21],"Arrhythmogenic Cardiomyopathy","PKP2-ACM","PKP2-ARVC",[19,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"ACM","Cardiomyopathy","ARVC","Arrhythmogenic Right Ventricular","Arrhythmogenic Right Ventricular Dysplasia","Genetic cardiomyopathy","Gene Therapy","PKP2 Gene","Plakophilin-2","LX2020","GRIT-PKP2","Ventricular Arrhythmia","PVCs","Sudden Cardiac Death","Cardiac Arrest","OBSERVATIONAL",[],{"count":41,"type":42},10,"ESTIMATED",[],[45],{"measure":46,"description":47,"timeFrame":48},"Percentage of subjects who experienced at least 1 treatment emergent adverse event (TEAE) and\u002For 1 treatment emergent serious adverse event (TESAE).","Evaluation of Safety and Tolerability of LX2020","4 years",[],"ALL","18 Years","67 Years",false,{"inclusion":55,"exclusion":57,"raw_text":59},[56],"Participants who received LX2020 in study LX2020-01",[58],"Concurrent enrollment in any other clinical investigation involving use of an investigational agent.","Inclusion Criteria:\n\n* Participants who received LX2020 in study LX2020-01\n\nExclusion Criteria:\n\n* Concurrent enrollment in any other clinical investigation involving use of an investigational agent.",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"University of Michigan","Ann Arbor","Michigan","48109","United States",{"lat":71,"lon":72},42.27756,-83.74088,[],[75],{"name":76,"affiliation":13,"role":77},"Lexeo Clinical Trials","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":81,"biomarkers":83},[82],"Arrhythmic cardiomyopathy",[30],{"nct_id":4,"found":53,"summary":15,"prompt_version":15}]