[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intravenous-immunoglobulin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intravenous-immunoglobulin":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Efgartigimod","Intravenous Immunoglobulin","Myasthenia Gravis Associated With Thymoma","NOT_YET_RECRUITING","2025-11-14",{"date":33,"type":34},"2025-11-17","ACTUAL",{"date":36,"type":21},"2025-12-01",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"Shanghai Zhongshan Hospital","OTHER"]