[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lexeo Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":124},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,62,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100648332","phase-2-study-of-lx2006-gene-therapy-in-friedreich-ataxia-cardiomyopathy-100648332",false,"NCT07721025","Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy","A Phase 2, Multicenter, Open-label, Randomized, Controlled Study of LX2006 Gene Therapy in Participants With Friedreich Ataxia Cardiomyopathy (SUNRISE-FA 2)","SUNRISE-FA 2","Inclusion Criteria:\n\n* Male or female, age at least 6 years at the time of signing the informed consent (and assent, if applicable).\n* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on the frataxin gene)\n* Onset of FA on or before 25 years of age\n* Confirmed left ventricular hypertrophy and abnormal left ventricular mass index\n* Left ventricular ejection fraction at least 30%\n* Anti-AAVrh.10 total antibody titer less than the protocol-specified maximum level\n\nExclusion Criteria:\n\n* Presence of other forms of cardiomyopathy that contribute to heart failure\n* Current use of inotrope infusion or presence of a ventricular assist device\n* Contraindication to cardiac MRI\n* Prior organ transplant\n* Previous gene transfer or cell therapy\n* Poorly controlled diabetes (hemoglobin A1c ≥8%)\n* Active hematologic or solid organ cancer\n\nOther inclusion\u002Fexclusion criteria to be applied as per protocol.","ALL","6 Years",{"count":20,"type":21},26,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).",[27,28],"Friedreich Ataxia","Cardiomyopathy, Secondary",[30,31,27,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,15,47,48],"Friedreich Ataxia Cardiomyopathy","FA-CM","Friedreich's Ataxia","FA","FRDA","Cardiomyopathy","Genetic Cardiomyopathy","Mitochondrial Cardiomyopathy","Cardiac Disease","Left Ventricular Hypertrophy","Hypertrophic Cardiomyopathy (Non-Obstructive)","HCM","Gene Therapy","FXN Gene","FXN","Frataxin Gene","LX2006","SUNRISE-FA","CLARITY","RECRUITING","2026-07-20",{"date":52,"type":53},"2026-07-22","ACTUAL",{"date":55,"type":53},"2026-06-25",{"date":57,"type":21},"2032-06",{"name":59,"class":60},"Lexeo Therapeutics","INDUSTRY",1,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100582605","clinical-course-of-disease-in-participants-with-fa-cm-100582605","NCT06865482","Clinical Course Of Disease In Participants With FA-CM","Characteristics And Clinical Course Of Disease In Participants With Cardiomyopathy Associated With Friedreich Ataxia (CLARITY-FA)","Inclusion Criteria:\n\n* Male or female, ages ≥6 years at the time of signing the informed consent (and assent, if applicable).\n* Diagnosis of FA, based on clinical phenotype and genotype (GAA expansion on both alleles or compound heterozygous), with onset of FA occurring at ≤25 years of age\n* Confirmed left ventricular hypertrophy (LVH)\n* Left ventricular ejection fraction ≥40%\n\nExclusion Criteria:\n\n* Presence of other form(s) of CM contributing to heart failure (HF), clinically significant cardiac anatomic abnormality or congenital cardiac malformation, clinically significant coronary artery, uncorrected, hemodynamically significant primary structural valvular disease not due to CM\n* Currently receiving intermittent or continuous intravenous (IV) inotrope infusion, presence of a ventricular assist device, or history of prior heart transplantation\n* Contraindication to cMRI, participants \\\u003C12 years of age who cannot complete the cMRI without sedation will instead undergo ECHOs and are exempt from this criterion.\n* Prior organ transplantation\n* Initiation of cardiac resynchronization therapy (CRT) within 6 months prior to screening.\n* History of prior gene transfer or cell therapy.\n* Poorly controlled diabetes (hemoglobin A1c ≥8%)\n* Active hematologic or solid organ malignancy",{"count":70,"type":21},65,"OBSERVATIONAL","Characteristics and clinical course of disease In participants with cardiomyopathy associated with Friedreich Ataxia (CLARITY-FA)",[27,35],[27,31,35,33,38],"2026-06-04",{"date":77,"type":53},"2026-06-08",{"date":79,"type":53},"2025-09-30",{"date":81,"type":21},"2027-09",{"name":59,"class":60},19,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":96,"studyType":71,"phases":4,"briefSummary":97,"conditions":98,"keywords":102,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":123},"100591144","a-study-to-assess-real-world-patient-characteristics-and-clinical-course-for-symptomatic-patients-with-pkp2-acm-100591144","NCT06976606","A Study to Assess Real-world Patient Characteristics and Clinical Course for Symptomatic Patients With PKP2-ACM","An Observational Study to Assess Real-world Patient Characteristics, Clinical Course, and Treatment Patterns for Symptomatic Patients With Arrhythmogenic Cardiomyopathy (ACM) Due To a PlaKoPhilin-2 Pathogenic Variant (PKP2)","SNAPSHOT- PKP2","Inclusion Criteria:\n\n* Adults with a clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC)\n* Documentation of a pathogenic or likely pathogenic truncating variant in PKP2\n* Frequent premature ventricular contractions (PVCs)\n* Patients must have an ICD placed prior to enrollment\n* Left ventricular ejection fraction (LVEF) ≥ 50% for Part A participants. Left ventricular ejection fraction (LVEF) ≥40% for Part B participants.\n\nExclusion Criteria:\n\n* Evidence of variant(s) in addition to PKP2 that meet standard criteria to be considered pathogenic or likely pathogenic for an arrhythmogenic cardiomyopathy.\n* A history of other cardiac abnormalities as specified in the protocol.\n* New York Heart Association symptoms of heart failure of Class IV at the time of consent.\n* A history of prior gene transfer therapy.","18 Years","65 Years",{"count":95,"type":21},40,"1 Year","An observational study to assess real-world patient characteristics and clinical course of disease in participants with PKP2-ACM.",[99,100,101],"Arrhythmogenic Cardiomyopathy","PKP2-ACM","PKP2-ARVC",[99,103,35,104,105,106,107,42,108,109,110,111,112,113,114,115],"ACM","ARVC","Arrhythmogenic Right Ventricular","Arrhythmogenic Right Ventricular Dysplasia","Genetic cardiomyopathy","PKP2 Gene","Plakophilin-2","LX2020","SNAPSHOT-PKP2","Ventricular Arrhythmia","PVCs","Sudden Cardiac Death","Cardiac Arrest","2025-05-13",{"date":118,"type":53},"2025-05-16",{"date":120,"type":53},"2024-01-23",{"date":81,"type":21},{"name":59,"class":60},6,""]