Using sirolimus to treat thrombocytopenia related to antiphospholipid antibodies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of sirolimus in patients with antiphospholipid antibody-related thrombocytopenia. Participants will be randomly assigned to receive either sirolimus or a placebo, with follow-up assessments at 2 weeks, 1 month, 3 months, and 6 months. The primary outcome is the overall response rate at 6 months, while secondary outcomes include complete and partial response rates and changes in antiphospholipid antibody titers. The study will help determine the effectiveness of sirolimus compared to a control group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times with 12 weeks apart)
* persistent thrombocytopenia (30-100×10\^9/L, at least for 2 weeks)

Eligible concomitant treatment:

* prednisone or equivalent dose less than 10mg per day is allowed, and dose should be stable for more than 2 weeks
* hydroxychloroquine less than 400mg per day is allowed, and dose should be stable for more than 1 month
* anti-platelet and/or anti-coagulant therapy is allowed, and strength should be the stable for 1 week
* these following therapies should be discontinued for more than 5 half-lives before the enrollment, including thrombopoietin or thrombopoietin receptor antagonist, intravenous immunoglobulin, immunosuppressants, B cell inhibitors (Belimumab or Talitacicept) and B cell depletion therapy (Rituximab or Obinutuzumab).

Exclusion Criteria:

* fulling the criteria of other connective tissue disease other than antiphospholipid syndrome
* received oral/intravenous antibiotics within 2 weeks before the enrollment.
* new onset of thrombosis within 4 weeks before the enrollment.
* apparent bleeding tendency.
* life or organ threatening manifestations, includes but not limit to catastrophic antiphospholipid syndrome and thrombotic microangiopathy.
* liver and renal dysfunction: ALT or AST more than three times of upper limit of normal range; eGFR\<40mL/min/1.73m\^2
* hematocytopenia: WBC\<3.0×10\^9/L, Hb\<100g/L.
* uncontrollable hyperlipidemia: low density lipoprotein cholesterol\>3.1 mmol/L, triglycerides\>2.3 mmol/L after lipid lowering therapy.
* current active infection
* women in pregnancy and postpartum period

Where it's running

• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shangdong, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting
• People's Hospital of Xinjiang Uygur Autonomous Region
  Ürümqi, Xinjiang, China Recruiting
• The 1st Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting
• Beijing Chao-Yang Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Lanlan Ji
• Email: thigh0829@163.com
• Phone: +86-010-83575130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.