The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Jul 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a medication called Sirolimus for patients with Primary Antiphospholipid Syndrome (APS), a condition that can cause blood clots and other health issues. The trial will track participants over 24 and 48 weeks to see how well the medication works compared to a placebo (a treatment that looks the same but has no active ingredients). The study is not currently recruiting participants, but when it is, adults aged 18 to 70 who meet specific health criteria for APS may be eligible to join.

To participate, individuals must be able to understand and sign a consent form and have a stable treatment plan in place. However, those with certain health issues, like recent serious blood clots or specific infections, will not be eligible. Participants can expect to receive either Sirolimus or a placebo, and their health will be monitored closely throughout the study. This research is crucial as it aims to find new treatment options for APS, potentially improving care for patients with this condition.

Gender

ALL

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