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:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT01727193
Eligibility Criteria:
Inclusion Criteria:
1. 12 to 65 years；
2. Myasthenia gravis:
1. Patients who are diagnosed as generalized or ocular myasthenia gravis
2. have experienced extended thymectomy (including thymic hyperplasia and thymoma)， no significant complications in 6 months after operation , and does not received any immunosuppressants or glucocorticoids treatments.
3. do not applied in plasmapheresis or immunoglobulins treatment during 3 months .
4. women of child-bearing period do not have a plan of pregnant for at least 3 year.
5. Written consent of the patient, after informing
Exclusion Criteria:
1. The liver , kidney or glycometabolic function is abnormal
2. Seriously complications, such as infection or symptom in central nervous system,
3. The patients who suffering from malignancy or a history of malignancy, a variety of sexually transmitted diseases and HIV infection, tuberculosis infection, and other condition which need to prohibit the use of immunosuppressive patients.
4. Be allergic to leflunomide, azathioprine
5. Pregnant or suckling period woman
6. Accompanied with mental disorders and have difficult to communication
7. Experienced myasthenia crisis in 3 months.
8. suffering from clear cardiopulmonary functional and brain abnormalities
9. Have a history of refractory hypertension or peptic ulcer .
10. One of the white blood cells, hemoglobin, and platelet count obvious abnormalities
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
65 Years
Study:
NCT01727193
Study Brief:
Protocol Section:
NCT01727193