NCT07231523尚未招募3 期
Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年12月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Quantitative Myasthenia Gravis (QMG) reduction
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged >18 years and ≤75 years, with an expected survival time >12 months;
- •Patients with generalized myasthenia gravis;
- •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.
排除标准
- •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;
- •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;
- •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;
- •Serum IgG level <4.5 g/L;
- •Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
- •Thrombosis, renal impairment or renal failure;
- •Allergic to human immunoglobulin or have other severe allergic history;
- •Selective IgA deficiency with anti-IgA antibodies;
- •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;
结局指标
主要结局
Quantitative Myasthenia Gravis (QMG) reduction
时间窗: From baseline to 2 weeks postoperatively
The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.
次要结局
- MG-ADL change (1 day preoperatively)(From baseline to 1 day preoperatively)
- MGC change (1 month postoperatively)(From baseline to 1 month postoperatively)
- Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction(From baseline to 2 weeks postoperatively)
- Myasthenia Gravis Composite (MGC) reduction(From baseline to 2 weeks postoperatively)
- MGC change (2 months postoperatively)(From baseline to 2 months postoperatively)
- IgG reduction (1 day preoperatively)(From baseline to 1 day preoperatively)
- IgG reduction (1 week postoperatively)(From baseline to 1 week postoperatively)
- IgG reduction (2 weeks postoperatively)(From baseline to 2 weeks postoperatively)
- IgG reduction (1 month postoperatively)(From baseline to 1 month postoperatively)
- IgG reduction (2 months postoperatively)(From baseline to 2 months postoperatively)
- AChR-Ab reduction (1 day preoperatively)(From baseline to 1 day preoperatively)
- AChR-Ab reduction (2 weeks postoperatively)(From baseline to 2 weeks postoperatively)
- AChR-Ab reduction (1 month postoperatively)(From baseline to 1 month postoperatively)
- Proportion of steroid dose reduction(From baseline to 2 months postoperatively)
- QMG change (1 day preoperatively)(From baseline to 1 day preoperatively)
- Incidence of myasthenic crisis(Perioperative period)
- Incidence of total perioperative complications (≥3)(Perioperative period)
- Incidence of perioperative infection-related complications(Perioperative period)
- MGC change (1 day preoperatively)(From baseline to 1 day preoperatively)
- QMG change (1 week postoperatively)(From baseline to 1 week postoperatively)
- QMG change (1 month postoperatively)(From baseline to 1 month postoperatively)
- QMG change (2 months postoperatively)(From baseline to 2 months postoperatively)
- MG-ADL change (1 week postoperatively)(From baseline to 1 week postoperatively)
- MG-ADL change (2 months postoperatively)(From baseline to 2 months postoperatively)
- MG-ADL change (1 month postoperatively)(From baseline to 1 month postoperatively)
- MGC change (1 week postoperatively)(From baseline to 1 week postoperatively)
研究者
研究点 (1)
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