Actively Recruiting
Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia
Led by Peking University First Hospital · Updated on 2025-07-04
84
Participants Needed
10
Research Sites
151 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
N
North China Pharmaceutical Co.,Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Persistent positive antiphospholipid antibody confirmed at least twice, 12 weeks apart
- Persistent thrombocytopenia with platelet count 30-100 x10^9/L for at least 2 weeks
- Prednisone or equivalent dose less than 10 mg per day with stable dose for more than 2 weeks allowed
- Hydroxychloroquine less than 400 mg per day with stable dose for more than 1 month allowed
- Anti-platelet and/or anti-coagulant therapy allowed with stable dose for at least 1 week
- Discontinuation of thrombopoietin, thrombopoietin receptor agonists, intravenous immunoglobulin, immunosuppressants, B cell inhibitors, and B cell depletion therapies for more than 5 half-lives before enrollment
You will not qualify if you...
- Diagnosis of other connective tissue diseases besides antiphospholipid syndrome
- Use of oral or intravenous antibiotics within 2 weeks before enrollment
- New thrombosis onset within 4 weeks before enrollment
- Apparent bleeding tendency
- Life- or organ-threatening manifestations including catastrophic antiphospholipid syndrome and thrombotic microangiopathy
- Liver dysfunction with ALT or AST more than three times the upper limit of normal
- Renal dysfunction with eGFR less than 40 mL/min/1.73 m^2
- Hematocytopenia with WBC less than 3.0 x10^9/L or hemoglobin less than 100 g/L
- Uncontrollable hyperlipidemia with LDL cholesterol above 3.1 mmol/L or triglycerides above 2.3 mmol/L after lipid-lowering therapy
- Current active infection
- Women who are pregnant or in the postpartum period
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
2
Qilu Hospital of Shandong University
Jinan, Shangdong, China, 250012
Actively Recruiting
3
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
4
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
5
The 1st Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Actively Recruiting
6
Beijing Chao-Yang Hospital
Beijing, China, 100020
Actively Recruiting
7
Peking University First Hospital
Beijing, China, 100034
Actively Recruiting
8
Peking University Third Hospital
Beijing, China, 100083
Actively Recruiting
9
Beijing Shijitan Hospital
Beijing, China
Actively Recruiting
10
Shanghai Renji Hospital
Shanghai, China, 200001
Actively Recruiting
Research Team
L
Lanlan Ji
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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