[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615924":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":70,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":11,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":97,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"a single Telitacicept treatment group","EXPERIMENTAL",null,[13],"Drug: Telitacicept",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Telitacicept","All enrolled pediatric patients with OMG who meet the inclusion criteria will receive subcutaneous injections of Telitacicept on top of their existing medication regimen. The dose will be adjusted according to the patient's body weight: 160 mg per dose for those weighing ≥40 kg; 80 mg per dose for those weighing between 20 kg and \\\u003C40 kg; for patients weighing \\\u003C20 kg or aged \\\u003C5 years, a gradual dose reduction may be considered based on individual circumstances. The administration schedule for Telitacicept (80 mg or 160 mg per dose) is as follows: once weekly via subcutaneous injection for the first 12 weeks; subsequently, once every two weeks via subcutaneous injection for the next 12 weeks; followed by once every four weeks via subcutaneous injection thereafter. Corticosteroids will be gradually tapered and discontinued based on changes in the patient's clinical condition.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Shanshan Mao","CONTACT","15990042668","6307003@zju.edu.cn",[27,44,58],{"facility":28,"status":11,"city":29,"state":30,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Shenzhen children's Hospital of China Medical University","Shenzhen","Guangdong","China","CN",{"type":34,"coordinates":35},"Point",[36,37],114.0683,22.54554,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":11,"email":43},"Xufeng Luo","19012770239","75172133@qq.com",{"facility":45,"status":11,"city":46,"state":47,"zip":11,"country":31,"countryCode":32,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"Children's Hospital Affiliated to Shandong University","Jinan","Shandong",{"type":34,"coordinates":49},[50,51],116.99722,36.66833,{"lat":51,"lon":50},[54],{"name":55,"role":23,"phone":56,"phoneExt":11,"email":57},"Kai Ma","18358628830","shdhmmk@126.com",{"facility":59,"status":11,"city":60,"state":61,"zip":62,"country":31,"countryCode":32,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The Children's Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310052",{"type":34,"coordinates":64},[65,66],120.16142,30.29365,{"lat":66,"lon":65},[69],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":71,"investigatorFullName":22,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Directo","100615924","a-study-on-the-efficacy-and-safety-of-telitacicept-in-the-treatment-of-children-ocular-myasthenia-gravis-100615924",false,"NCT07298928","A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis","The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health","Inclusion Criteria:\n\n1. The patient and their legal guardian voluntarily sign the informed consent form.\n2. Age \\\u003C 18 years, male or female.\n3. Diagnosis of OMG according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition).\n4. Stable administration of any one or combination of the following standard treatments prior to enrollment:\n\n   1. Cholinesterase inhibitors\n   2. Glucocorticoids\n\nExclusion Criteria:\n\n1. Active infection under treatment： Patients who are HBsAg positive must be excluded. Patients who are HBsAg negative but HBcAb positive must undergo quantitative HBV-DNA testing. Patients with a positive quantitative HBV-DNA result must be excluded; those with a negative result may be enrolled.\n2. Severe hepatic or renal insufficiency.\n3. Patients with malignant tumors other than thymoma.\n4. Patients within 3 months post-thymectomy.\n5. Hypogammaglobulinemia (IgG \\\u003C 400 mg\u002FdL) or IgA deficiency (IgA \\\u003C 10 mg\u002FdL).\n6. History of allergy to human-derived biological products.\n7. Participation in any other clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug from the previous trial (whichever is longer).\n8. Patients deemed unsuitable for participation by the investigator (e.g., patients with severe psychiatric disorders).","ALL","18 Years",{"count":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87],"NA","Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in national multicenter clinical trials for adult OMG. Our center published a retrospective study in the Chinese Journal of Evidence-Based Pediatrics in August 2025, which was the first report both domestically and internationally on the efficacy and safety of Telitacicept in four pediatric OMG patients. This study plans to conduct a prospective, multicenter, open-label, single-arm clinical trial aimed at evaluating the effectiveness and safety of Telitacicept in pediatric OMG.",[90],"Effectiveness",[92,93,17,94,95,96],"long-term follow-up","Ocular myasthenia gravis","Children","Biological agent","Targeted treatment","NOT_YET_RECRUITING","2026-03-05",{"date":100,"type":101},"2026-03-06","ACTUAL",{"date":103,"type":84},"2026-03-10",{"date":105,"type":84},"2028-12",{"name":5,"class":6},3]