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RECRUITING
NCT06722586
PHASE4

Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia: a Multicenter Randomized, Double Blind, Placebo Controlled, Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-01-07

Completion Date

2027-12

Last Updated

2025-07-04

Healthy Volunteers

No

Interventions

DRUG

Sirolimus

Sirolimus two pills (1mg) per day

DRUG

Placebo

Placebo two pills per day

Locations (10)

Xiangya Hospital of Central South University

Changsha, Hunan, China

Qilu Hospital of Shandong University

Jinan, Shangdong, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

The 1st Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Chao-Yang Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Beijing Shijitan Hospital

Beijing, China

Shanghai Renji Hospital

Shanghai, China