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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sirolimus
  • Placebo

Treatment groups

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations