Overview

Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia

Status:
RECRUITING
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn the efficacy and safety of sirolimus in the treatment of anti-phospholipid antibody associated thrombocytopenia. The patients would be followed at 2 weeks, 1 month, 3 months, and 6 months after the enrollment. The main questions it aims to answer are the differences between sirolimus and control group at below outcomes: Primary outcome: the overall response rate at 6 months Secondary outcome: the complete response rate at 6 months the partial response rate at 6 months the change of anti-phospholipid antibody titers the change of oral glucocorticoids dosage Other pre-defined outcome: the dropout rate within 6 months Participants will receive either sirolimus 1mg per day or placebo.
Phase:
PHASE4
Details
Lead Sponsor:
Peking University First Hospital
Collaborator:
North China Pharmaceutical Co.,Ltd
Treatments:
Sirolimus