Compares two treatments for myasthenia gravis linked to thymoma
Tests efgartigimod against immunoglobulin around thymus removal in thymoma-linked myasthenia gravis.
Plain-language title generated from the registry record
Registry title: EFG vs IVIG in TAMG
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07231523, who can take part
Where in China
- Shanghai Zhongshan HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT07231523
- Record updated
- 17 November 2025
- Original description
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.Read full original descriptionShow less
Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study
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.
Inclusion: Patients aged >18 years and ≤75 years, with an expected survival time >12 months; Patients with generalized myasthenia gravis; MG-ADL ≥6; Positive for AChR antibody; Diagnosed with thymoma by enhanced chest CT or MRI; Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy; Patients with American Society of Anesthesiologists (ASA) grade 1-2; Able to understand the study situation and sign the Informed Consent.
Exclusion: 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; Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month; Selective IgA deficiency with anti-IgA antibodies; 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; History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation); Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders; Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers; 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; 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; Thrombosis, renal impairment or renal failure; Allergic to human immunoglobulin or have other severe allergic history; 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; Serum IgG level <4.5 g/L; Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:; Blood: white blood cells <4.0×10\^9/L, absolute neutrophil count (ANC) <2.0×10\^9/L, platelet count <100×10\^9/L, hemoglobin <90g/L; 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/L, creatinine clearance rate (CCr) <60 ml/min; MGFA type V; Patients who have undergone median sternotomy; Patients participating in other clinical studies simultaneously.