EFG vs IVIG in TAMG (NCT07231523) | Clinical Trial Compass
Not Yet RecruitingPhase 3
EFG vs IVIG in TAMG
China64 participantsStarted 2025-12-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. MGFA type V;
✕. Patients who have undergone median sternotomy;
✕. 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;
✕. 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;
What they're measuring
1
Quantitative Myasthenia Gravis (QMG) reduction
Timeframe: From baseline to 2 weeks postoperatively
✕. 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;
✕. 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 participating in other clinical studies simultaneously;