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Clinical Trials in China / NCT07231523
Starting soon Phase 3

EFG vs IVIG in TAMG

NCT07231523 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Phase 3
Started
2025-12-01
Last updated
2025-11-17

Condition(s) studied

EfgartigimodIntravenous ImmunoglobulinMyasthenia Gravis Associated With Thymoma

Investigational drug(s) / intervention(s)

Efgartigimod + ThymectomyIntravenous immunglobulin + Thymectomy

Efgartigimod + Thymectomy: Patients receive weight-based EFG infusions (10 mg/kg; 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.

Intravenous immunglobulin + Thymectomy: Patients receive weight-based IVIG infusions (400 mg/kg) 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Zhongshan Hospital Shanghai Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07231523 on ClinicalTrials.gov ↗ ← All trials in China