Eligibility Module

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: 2025-12-24 @ 4:50 PM
Ignite Modification Date: 2025-12-24 @ 4:50 PM
NCT ID: NCT00515450
Eligibility Criteria: Inclusion Criteria: * Patients diagnosed as generalized myasthenia gravis * Patients who are not controlled by current therapy and need plasmapheresis therapy * Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent * Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment Exclusion Criteria: * Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment * Patients who had undergone thymectomy within 24 weeks prior to enrollment * Patients with 3 points item in bulbar symptom of MG-ADL scale * Patients with severe hepatic disorder, severe renal disorder or severe heat disorder * Patients who have received treatment of malignant tumors * Patients who have the anamnesis of shock or hypersensitivity to this drug * Patients who have been diagnosed as hereditary fructose intolerance * Patients who have the anamnesis of cerebral infarction or symptom of these diseases * Patients who have been diagnosed as IgA deficiency in their past history * Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant * Patients who were administered other investigational drug within 12 weeks before consent
Healthy Volunteers: False
Sex: ALL
Minimum Age: 16 Years
Study: NCT00515450
Study Brief:
Protocol Section: NCT00515450