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Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia
Sponsor: Peking University First Hospital
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
Sirolimus
Sirolimus two pills (1mg) per day
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