[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613334":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":41,"collaborators":20,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":20,"eligibilityCriteria":48,"healthyVolunteers":45,"sex":49,"minAge":50,"maxAge":20,"enrollmentInfo":51,"targetDuration":20,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":20,"overallStatus":24,"whyStopped":20,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"fullName":5,"class":6},"Lantu Biopharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"The selected dose inchildren ≥ 6 months of age","EXPERIMENTAL","Administration the selected dose of Vesemnogene Lantuparvovec in children \\> 6 months of age",[13],"Biological: vesemnogene lantuparvovec",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","vesemnogene lantuparvovec","Exploratory study evaluating the safety and efficacy of vesemnogene lantuparvovec in patients with SMA.",[9],null,[22],{"facility":23,"status":24,"city":25,"state":26,"zip":27,"country":26,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Tzu chi hospital","RECRUITING","Jakarta","Indonesia","14470","ID",{"type":30,"coordinates":31},"Point",[32,33],106.84513,-6.21462,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Putri","CONTACT","+62 21 50950888","pedonco.tch@tzuchihospital.co.id",{"type":42,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100613334","phase-3-real-world-clinical-effectiveness--safety-of-vesemnogene-lantuparvovec-for-spinal-muscular-atrophy-sma-in-low-middle-income-countries-lmic-100613334",false,"NCT07265232","Real World Clinical Effectiveness & Safety of Vesemnogene Lantuparvovec for Spinal Muscular Atrophy (SMA) in Low-middle Income Countries (LMIC).","Inclusion Criteria:\n\n1. Willing and able to give written informed consent for participation in the study.\n2. Genetic confirmation of SMA (biallelic deletion or mutation of SMN1).\n3. SMA clinical phenotype and condition, that in the opinion of the treating physician, treatment with Vesemnogene will likely be beneficial.\n4. Absence of contraindications for spinal tap procedure or administration of intrathecal therapy.\n5. Total AAV antibody titres \\\u003C 1:20 as determined by ELISA assay.\n6. Normal liver function (AST\u002FALT \\\u003C 3XULN, Bilirubin \\\u003C3.0 mg\u002FdL).\n7. Unable to access or failure to respond to currently available curative treatments for SMA.\n\nExclusion Criteria:\n\nNone","ALL","6 Months",{"count":52,"type":53},15,"ESTIMATED","INTERVENTIONAL",[56],"PHASE3","The study objective is to determine the real-world safety and effectiveness of Vesemnogene lantuparvovec for the treatment of SMA.\n\nThe specific objectives are:\n\n* To determine clinical effectiveness of Vesemnogene lantuparvovec therapy for SMA as evaluated by developmental gross motor milestone and survival.\n* To describe the safety profile of Vesemnogene therapy for SMA as evaluated by adverse events reporting and laboratory tests, and monitoring of Adverse events of special interest.",[59],"Spinal Muscular Atrophy (SMA)","2025-12-02",{"date":62,"type":63},"2025-12-04","ACTUAL",{"date":65,"type":63},"2025-10-15",{"date":67,"type":53},"2030-10-15",{"name":5,"class":6},1]