Clinical trial Phase 3 Interventional Ages 18 to 75

EFG vs IVIG in TAMG

Run by Shanghai Zhongshan Hospital · NCT07231523 · Data updated 2026-11-12

Not yet open. This study is not taking new participants. Its registered completion date is 2027-06-01.

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.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment64 (estimated)
SponsorShanghai Zhongshan Hospital
Academic / other
Drugs / interventionsEfgartigimod + Thymectomy, Intravenous immunglobulin + Thymectomy
Locations1 site (China)
Trial IDNCT07231523 on ClinicalTrials.gov

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients aged \>18 years and ≤75 years, with an expected survival time \>12 months;
2. Patients with generalized myasthenia gravis;
3. MG-ADL ≥6;
4. Positive for AChR antibody;
5. Diagnosed with thymoma by enhanced chest CT or MRI;
6. Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;
7. Patients with American Society of Anesthesiologists (ASA) grade 1-2;
8. Able to understand the study situation and sign the Informed Consent.

Exclusion Criteria:

1. MGFA type V;
2. Patients who have undergone median sternotomy;
3. 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;
4. 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;
5. 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;
6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
7. Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;
8. Patients participating in other clinical studies simultaneously;
9. Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;
10. 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;
11. 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;
12. Serum IgG level \<4.5 g/L;
13. Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
14. Thrombosis, renal impairment or renal failure;
15. Allergic to human immunoglobulin or have other severe allergic history;
16. Selective IgA deficiency with anti-IgA antibodies;
17. 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;

Where it's running

  • Shanghai Zhongshan Hospital
    Shanghai, Shanghai Municipality, China

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.