[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578007":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":33,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":10,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"iECURE, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enrolled and Dosed",null,"Previously dosed in a previous iECURE study.",[13],"Other: No Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Enrolled but Not Dosed","Enrolled in a previous iECURE study, but not dosed.",[13],[19],{"type":20,"name":21,"description":21,"armGroupLabels":22,"otherNames":10},"OTHER","No Intervention",[9,15],[24],{"name":25,"affiliation":5,"role":26},"George Diaz, M.D., Ph.D","STUDY_DIRECTOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":10,"email":32},"George Diaz, M.D., Ph.D.","CONTACT","1-877-694-3558","medinfo@iecure.com",[34],{"facility":35,"status":36,"city":37,"state":10,"zip":10,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Great Ormond Street Hospital","RECRUITING","London","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-0.12574,51.50853,{"lat":44,"lon":43},[47],{"name":48,"role":30,"phone":10,"phoneExt":10,"email":49},"Christopher Jackson","christopher.jackson@gosh.nhs.uk",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100578007","long-term-follow-up-ltfu-study-of-participants-in-any-iecure-protocol-using-an-investigational-product-ip-100578007",false,"NCT06805695","Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)","Inclusion Criteria:\n\n1. Enrolled in an iECURE parent protocol and have either completed or discontinued that protocol\n2. Participant parent(s)\u002FLAR is willing and able to adhere to the protocol requirements.\n3. Consent was obtained by the participants parent(s)\u002FLAR (and participant assent, where applicable), prior to any study-related data being collected.\n\nExclusion Criteria:\n\n1\\. Participants who enroll into an interventional drug or gene therapy clinical trial utilizing an IP other than the IP provided in the parent protocol will be excluded from this protocol.","ALL","7 Months","15 Months",{"count":62,"type":63},13,"ESTIMATED","OBSERVATIONAL","This LTFU is being conducted to assess long-term safety and durability of response in participants dosed with IP in a parent protocol, and to collect longitudinal natural history in enrolled but not dosed participants who also participated in a parent protocol.",[67,68,69],"Ornithine Transcarbamylase Deficiency","Ornithine Transcarbamylase Deficiency Disease","Urea Cycle Disorders, Inborn",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,67,92,93,94,95,96,97,98,99,100],"Amino Acid Metabolism, Inborn Errors","Ammonia","Brain Diseases","Brain Diseases, Metabolic","Brain Diseases, Metabolic, Inborn","Central Nervous System Diseases","Genetic Diseases, Inborn","Genetic Diseases, X-Linked","High Ammonia","Hyperammonemia","Inborn","Inborn Errors","Liver Disease","Liver Transplant","Metabolism","Metabolic Diseases","Metabolism, Inborn Errors","Neonatal","Nervous System Diseases","NH4","Ornithine","OTC","OTC Deficiency","OTCD","Transcarbamylase","UCD","Urea Cycle Disorders","Long Term Follow Up","Long-Term Follow-Up","LTFU","2025-01-28",{"date":103,"type":104},"2025-02-03","ACTUAL",{"date":106,"type":104},"2024-12-23",{"date":108,"type":63},"2041-07",{"name":5,"class":6},1]