Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT07298928
Eligibility Criteria:
Inclusion Criteria:
1. The patient and their legal guardian voluntarily sign the informed consent form.
2. Age \< 18 years, male or female.
3. Diagnosis of OMG according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition).
4. Receiving corticosteroid therapy prior to enrollment.
Exclusion Criteria:
1. Active infection under treatment： Patients who are HBsAg positive must be excluded. Patients who are HBsAg negative but HBcAb positive must undergo quantitative HBV-DNA testing. Patients with a positive quantitative HBV-DNA result must be excluded; those with a negative result may be enrolled.
2. Severe hepatic or renal insufficiency.
3. Patients with malignant tumors other than thymoma.
4. Patients within 3 months post-thymectomy.
5. Hypogammaglobulinemia (IgG \< 400 mg/dL) or IgA deficiency (IgA \< 10 mg/dL).
6. History of allergy to human-derived biological products.
7. Participation in any other clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug from the previous trial (whichever is longer).
8. Patients deemed unsuitable for participation by the investigator (e.g., patients with severe psychiatric disorders).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT07298928
Study Brief:
Protocol Section:
NCT07298928