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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT01828294
Eligibility Criteria:
Inclusion Criteria:
1. AChR Ab positive myasthenia gravis (acetylcholine receptor antibody).
2. Age 18-80 years.
3. MGFA Classification II-IV (The scale used to determine the severity of symptoms of MG).
4. Receiving \> or equal 30mg of Prednisone per day.
5. No new MG-specific treatments in prior 3 months.
6. Willingness to participate in study protocol.
7. QMG \> 10 (quantitative myasthenia gravis score: the sum of grades given for symptoms of MG).
8. Treatment with any immunomodulator \> than or equal to 3 months prior to trial initiation.
Exclusion Criteria:
1. IgA deficiency (a major class of immunoglobulins found in serum and external body secretions such as saliva, tears, and sweat as well as in the gastrointestinal, respiratory, and genitourinary tracts).
2. Previous thromboembolic events, including deep vein thrombosis, stroke and myocardial infarction
3. MGFA Class I, IV (if patient requires hospitalization) or V
4. History of thymoma
5. Thymectomy in previous year or planning to undergo thymectomy in next six months
6. Pregnancy or lactation; unwillingness to avoid pregnancy
7. Serious concurrent medical, neurological or psychiatric condition that would interfere with IGSC administration or subsequent clinical assessments
8. Unwillingness or incapacity to participate, agree to necessary follow-up visits, or give written and informed consent
9. Patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin or to components of Hizentra, such as polysorbate 80, or patients with hyperprolinemia because it contains the stabilizer L-proline
10. Cholinesterase inhibitor no more than 240 mg/day
11. Body weight greater than 120 kg.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01828294
Study Brief:
Protocol Section:
NCT01828294