[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610741":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":33,"responsibleParty":48,"collaborators":50,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":11,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":93,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Efgartigimod + Thymectomy","EXPERIMENTAL",null,[13],"Combination Product: Efgartigimod + Thymectomy",{"label":15,"type":16,"description":11,"interventionNames":17},"Intravenous immunglobulin + Thymectomy","ACTIVE_COMPARATOR",[18],"Combination Product: Intravenous immunglobulin + Thymectomy",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"COMBINATION_PRODUCT","Patients receive weight-based EFG infusions (10 mg\u002Fkg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Patients receive weight-based IVIG infusions (400 mg\u002Fkg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Jianyong Ding","CONTACT","+86 18616881268","ding.jianyong@zs-hospital.sh.cn",[34],{"facility":5,"status":11,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Shanghai","Shanghai Municipality","200032","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51,53,55,57,59,61,63,65,68,70],{"name":52,"class":6},"The Affiliated Hospital of Xuzhou Medical University",{"name":54,"class":6},"First Affiliated Hospital of Wenzhou Medical University",{"name":56,"class":6},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"name":58,"class":6},"Tang-Du Hospital",{"name":60,"class":6},"West China Hospital",{"name":62,"class":6},"Second Affiliated Hospital of Soochow University",{"name":64,"class":6},"Huashan Hospital",{"name":66,"class":67},"The Affiliated Brain Hospital of Nanjing Medical University","OTHER_GOV",{"name":69,"class":6},"The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine",{"name":71,"class":6},"Wuhan TongJi Hospital","100610741","phase-3-efg-vs-ivig-in-tamg-100610741",false,"NCT07231523","EFG vs IVIG in TAMG","Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Patients aged \\>18 years and ≤75 years, with an expected survival time \\>12 months;\n2. Patients with generalized myasthenia gravis;\n3. MG-ADL ≥6;\n4. Positive for AChR antibody;\n5. Diagnosed with thymoma by enhanced chest CT or MRI;\n6. Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;\n7. Patients with American Society of Anesthesiologists (ASA) grade 1-2;\n8. Able to understand the study situation and sign the Informed Consent.\n\nExclusion Criteria:\n\n1. MGFA type V;\n2. Patients who have undergone median sternotomy;\n3. Confirmed history of congestive heart failure; poorly controlled angina pectoris with drug treatment; electrocardiogram (ECG) confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;\n4. Patients with weight loss of more than 5kg in the past month; severe uncontrolled systemic disease, such as active infection or poorly controlled diabetes; patients with hemorrhagic diseases and bleeding tendencies; coagulation dysfunction, bleeding tendency or receiving thrombolytic or anticoagulant therapy; patients with grade II-IV bone marrow suppression;\n5. Females with positive serum pregnancy test or in lactation period, and males and females of childbearing age who are unwilling to use adequate contraceptive measures during treatment;\n6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n7. Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;\n8. Patients participating in other clinical studies simultaneously;\n9. Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;\n10. Patients in the acute inflammatory period due to bacterial, viral or other microbial infections; known active infections of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), or known HIV seropositivity;\n11. Patients who have undergone thoracic surgery due to tuberculous pleurisy, mesothelioma, lung disease, or diaphragmatic disease, with ipsilateral lung atelectasis involving one lobe or more than one lobe;\n12. Serum IgG level \\\u003C4.5 g\u002FL;\n13. Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;\n14. Thrombosis, renal impairment or renal failure;\n15. Allergic to human immunoglobulin or have other severe allergic history;\n16. Selective IgA deficiency with anti-IgA antibodies;\n17. Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:\n\nBlood: white blood cells \\\u003C4.0×10\\^9\u002FL, absolute neutrophil count (ANC) \\\u003C2.0×10\\^9\u002FL, platelet count \\\u003C100×10\\^9\u002FL, hemoglobin \\\u003C90g\u002FL; Liver function: serum bilirubin \\>1.5 times the upper normal limit; ALT and AST \\>1.5 times the upper normal limit; Renal function: serum creatinine (SCr) \\>120 μmol\u002FL, creatinine clearance rate (CCr) \\\u003C60 ml\u002Fmin;","ALL","18 Years","75 Years",{"count":83,"type":84},64,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.",[90,91,92],"Efgartigimod","Intravenous Immunoglobulin","Myasthenia Gravis Associated With Thymoma","NOT_YET_RECRUITING","2025-11-14",{"date":96,"type":97},"2025-11-17","ACTUAL",{"date":99,"type":84},"2025-12-01",{"date":101,"type":84},"2027-12-01",{"name":5,"class":6},1]