Status:
NOT_YET_RECRUITING
The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study
Lead Sponsor:
Peking University People's Hospital
Conditions:
Primary Antiphospholipid Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is an Investigator initiated, randomized, multicenter, double-blind, placebo-control study. The aim of this study is to evaluate the safety and efficiency of Sirolimus for primaty antiphosp...
Eligibility Criteria
Inclusion
- Understand and sign the informed consent form
- Male or Female
- aged 18-70 at the time of screening visit
- Met 2006 Sapporo classification criteria of APS or 2023 ACR/EULAR classification criteria of APS
- With the stable combination therapy
Exclusion
- history of serious adverse events or contraindication to Sirolimus
- Catastrophic APS within 90 days
- Acute thrombosis within 30 days
- ≥4/11 American College of Rheumatology Classification Criteria for SLE or other systemic autoimmune diseases
- Historically positive HIV test or test positive at screening for HIV
- currently on any suppressive therapy for a chronic infection (such as tuberculosis, hepatitis B infection, hepatitis C infection, CMV, EBV, Syphilis, etc)
- Surgery treatment within one month
- History of malignant neoplasm within the last 5 years
- White blood cell counts\<3×10\*9/L
- 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
- Pregnant or pregnancy preparation or breastfeed
- Any circumstances that may cause the subjects to be unable to complete the study or pose significant risks to the subjects
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06504420
Start Date
October 15 2024
End Date
December 30 2027
Last Update
September 19 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.