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.
Complete response: the platelet count is more that 100×10\^9/L Partial response: If the platelet count is less than 100×10\^9/L, it should be more than 2 times of the baseline count Overall response: both complete and partial response
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGQilu Hospital of Shandong University
Jinan, Shangdong, China
RECRUITINGWest China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGPeople's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
RECRUITINGThe 1st Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGBeijing Chao-Yang Hospital
Beijing, China
RECRUITINGPeking University First Hospital
Beijing, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGBeijing Shijitan Hospital
Beijing, China
RECRUITINGShanghai Renji Hospital
Shanghai, China
RECRUITINGOverall response
Both complete response and partial response
Time frame: From enrollment to the end of treatment at 6 months
Complete response
Platelet count more than 100×10\^9/L
Time frame: From enrollment to the end of treatment at 6 months
Partial response
If the platelet count is less than 100×10\^9/L, it should be more than 2 times of the baseline platelet count
Time frame: From enrollment to the end of treatment at 6 months
The change of antiphospholipid antibodies titers
The changes of titers of antiphospholipid antibodies comparing to that of baseline
Time frame: From enrollment to the end of treatment at 6 months
The change of oral glucocorticoids dosage
The differences of oral glucocorticoids dosage change between two groups
Time frame: From enrollment to the end of treatment at 6 months
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