The Safety and Efficiency of Sirolimus in Primary Antiphospholipid Syndrome: a Randomized Control Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sirolimus, Placebo.
- Who it may be relevant to
- Registry conditions: Primary Antiphospholipid Syndrome. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients
Overview
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 antiphospholipid syndrome patients at week 24 and week 48.
Interventions
- Drug Sirolimus
Subjects will receive Sirolimus 1.5mg/d for 48 weeks in addition to their ongoing APS treatment regimen - Drug Placebo
Subjects will receive Placebo 1.5mg/d for first 24 weeks and Sirolimus 1.5mg/d for next 24 weeks in addition to their ongoing APS treatment regimen
Primary outcome measures
- Complete response(CR) rate at week 24 [Time frame: week 24]
- Partial response (PR) rate at week 24 [Time frame: week 24]
Secondary outcome measures (3)
- Complete response(CR) rate at week 48 [Time frame: week 48]
- Partial response (PR) rate at week 48 [Time frame: week 48]
- Rate of Participants with adverse effects and serious adverse effects during treatment [Time frame: baseline to week 48]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06504420 · 20240125