NCT06504420

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

A Randomized, Multicenter, Double-blind, Placeobo-control Study of Sirolimus for Primary Antiphospholipid Syndrome Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 antiphospholipid syndrome patients at week 24 and week 48.

Conditions

• Primary Antiphospholipid Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-07-16
• Last updated: 2024-09-19