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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT06504420
Eligibility Criteria:
Inclusion Criteria:
1. Understand and sign the informed consent form
2. Male or Female
3. aged 18-70 at the time of screening visit
4. Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
5. With the stable combination therapy
Exclusion Criteria:
1. history of serious adverse events or contraindication to Sirolimus
2. Catastrophic APS within 90 days
3. Acute thrombosis within 30 days
4. ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
5. Historically positive HIV test or test positive at screening for HIV
6. currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
7. Surgery treatment within one month
8. History of malignant neoplasm within the last 5 years
9. White blood cell counts\<3×10\*9/L
10. Abnormal Liver function tests: ALT or AST ≥ 1.5 times the upper limit of the normal value, and total bilirubin and blood lipids ≥ 2 times the upper limit of the normal value
11. Pregnant or pregnancy preparation or breastfeed
12. Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06504420
Study Brief:
Protocol Section:
NCT06504420