[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"efgartigimod\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:efgartigimod":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100610741","phase-3-efg-vs-ivig-in-tamg-100610741",false,"NCT07231523","EFG vs IVIG in TAMG","Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Patients aged \\>18 years and ≤75 years, with an expected survival time \\>12 months;\n2. Patients with generalized myasthenia gravis;\n3. MG-ADL ≥6;\n4. Positive for AChR antibody;\n5. Diagnosed with thymoma by enhanced chest CT or MRI;\n6. Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;\n7. Patients with American Society of Anesthesiologists (ASA) grade 1-2;\n8. Able to understand the study situation and sign the Informed Consent.\n\nExclusion Criteria:\n\n1. MGFA type V;\n2. Patients who have undergone median sternotomy;\n3. 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;\n4. 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;\n5. 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;\n6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n7. Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;\n8. Patients participating in other clinical studies simultaneously;\n9. Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;\n10. 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;\n11. 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;\n12. Serum IgG level \\\u003C4.5 g\u002FL;\n13. Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;\n14. Thrombosis, renal impairment or renal failure;\n15. Allergic to human immunoglobulin or have other severe allergic history;\n16. Selective IgA deficiency with anti-IgA antibodies;\n17. Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:\n\nBlood: white blood cells \\\u003C4.0×10\\^9\u002FL, absolute neutrophil count (ANC) \\\u003C2.0×10\\^9\u002FL, platelet count \\\u003C100×10\\^9\u002FL, hemoglobin \\\u003C90g\u002FL; 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\u002FL, creatinine clearance rate (CCr) \\\u003C60 ml\u002Fmin;","ALL","18 Years","75 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27,28,29],"Efgartigimod","Intravenous Immunoglobulin","Myasthenia Gravis Associated With Thymoma","NOT_YET_RECRUITING","2025-11-14",{"date":33,"type":34},"2025-11-17","ACTUAL",{"date":36,"type":21},"2025-12-01",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"Shanghai Zhongshan Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100561261","phase-3-seronegative-myasthenia-gravis---efgartigimod-iv-100561261","NCT06587867","Seronegative Myasthenia Gravis - Efgartigimod IV","Efficacy, Safety and Tolerability of Efgartigimod in Patients with Seronegative Generalized Myasthenia Gravis: an Open-Label Study","Inclusion Criteria:\n\n* Evidence of signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the trial. Subjects must be willing and able to comply with the protocol, complete study assessments, and return for follow-up visits.\n* Male or female subjects ≥ 18 years old.\n* Diagnosis of SN MG defined as: (a) clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition, (b) abnormal neuromuscular transmission test results demonstrated by single-fiber electromyography or repetitive nerve stimulation; and (c) negative serologic test for anti-AChR and anti- MuSK antibodies as confirmed at screening, (d) limited, if any, response to therapy with immunotherapy and\u002For antiacetylcholinesterase (AChE) treatment. Further testing for low affinity antibodies to rapsyn-clustered AChR by cell-based assays will be done at baseline and the results included as part of subgroup analysis. All patients will have a negative genetic test for congenital myasthenic syndromes by history or at baseline to exclude the possibility of congenital myasthenic syndrome mimicking SN MG.\n* MGFA Clinical Classification Class II, III, or IV at the time of screening and baseline.\n* Moderate to severe myasthenia gravis as defined by a generalized myasthenia gravis impairment index score \\> 11 or MG-ADL score of at least 5 (with \\>50% of the score due to non-ocular symptoms) and a PASS response of \"No\" and a SSQ of \\\u003C 70% with at least 6 months of historical data as the baseline.\n* Stable or worsening MG as defined by MGII remaining stable or increasing in the 4 week run-in interval.\n* Patients are required to be on a stable dose of their MG treatment (Standard of care-SoC) for at least one month prior to screening. The SoC is limited to AChE inhibitors, steroids and NSISTs (e.g., azathioprine, methotrexate, cyclosporine, tacrolimus, and mycophenolate mofetil. There is no requirement for specific generalised myasthenia gravis therapies.\n* Patients who discontinued early from previous trials of efgartigimod for reasons other than pregnancy, rescue therapy or a SAE can be included.\n* Females of childbearing potential who are sexually active with a non-sterilized male partner must be willing to use at least one highly effective contraception method from the time of screening and for 3 months after the final dose of efgartigimod.\n* Non-sterilized males who are sexually active with a female partner of childbearing potential must be willing to use a condom for the duration of the study and for 3 months after the last dose of efgartigimod. Because male condom is not a highly effective contraception method, it is strongly recommended that female partners of a male study subject also use a highly effective method of contraception throughout this period.\n* Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.\n* Patient has documented IgG \\>6 g\u002FL within one month of screening\n* Vaccinated for COVID-19 at least 2 weeks prior to screening visit.\n\nExclusion Criteria:\n\n* Patients who discontinued early from trials of efgartigimod for pregnancy or rescue reasons or an SAE that was likely to result in a life-threatening situation or pose a serious safety risk.\n* Pregnant and lactating women, and those intending to become pregnant during the trial or within 3 months after the last dosing. Women of childbearing potential should have a negative urine pregnancy test at screening and baseline.\n* Male patients who are sexually active and do not intend to use effective methods of contraception (as mentioned above) during the trial or within 3 months after the last dosing or male patients who plan to donate sperm during the trial or within 3 months after the last dosing.\n* Patients with known hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) seropositivity.\n* Patients with known autoimmune disease other than MG (e.g., rheumatoid arthritis) which in the investigator opinion would interfere with an accurate assessment of clinical symptoms.\n* Patients with clinical evidence of other significant disease or patients who underwent a recent major surgery, which could confound the results of the trial or put the patient at undue risk.\n* Patients with renal\u002Fhepatic function impairment as defined by (Cr\\>1.5 x elevated) and\u002For (transaminases \\> 2.5 x elevation) at screening.\n* Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.\n* Patients who have received rituximab or eculizumab in the 6 months before screening.\n* Patients who have undergone thymectomy within 3 months of screening.\n* Patients who had intravenous immunoglobulin or plasma exchange within 4 weeks of screening.\n* Patient who has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening\n* Patient has received a live or a live-attenuated vaccination during the month before screening",{"count":51,"type":21},30,[24],"This is to study the efficacy, safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis. This is an open label study. There will be 30 participants to enroll at University Health Network Toronto General Hospital. Study duration is 43 weeks from screening to end of study.",[27,55],"Generalized Myasthenia Gravis",[57,58],"seronegative","generalized myasthenia gravis","RECRUITING","2024-09-04",{"date":62,"type":34},"2024-09-19",{"date":64,"type":34},"2023-06-01",{"date":66,"type":21},"2025-05",{"name":68,"class":41},"University Health Network, Toronto"]