New drug may offer better control for rare Muscle-Weakening disease before surgery
NCT ID NCT07231523
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a newer drug, efgartigimod, works better than standard intravenous immunoglobulin (IVIG) for people with myasthenia gravis who also have a thymoma tumor and need surgery. About 64 adults will receive either treatment before and after their operation to see which one improves muscle strength and daily activities more. The goal is to find a safer, more effective option to manage symptoms during this critical time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.