AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia

RecruitingPhase 4Ages 18 Years - anyAllPeking University First Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to evaluate the efficacy and safety of sirolimus in patients with anti-phospholipid antibody-associated thrombocytopenia. In the 6-month randomized, double-blind, placebo-controlled phase, participants will receive either sirolimus 1 mg once daily or matching placebo. Participants will be followed at 2 weeks, 1 month, 3 months, and 6 months after enrollment. Participants who do not achieve the primary endpoint at 6 months may enter a 3-month open-label extension and receive sirolimus 1.5 mg once daily, with follow-up through month 9. The main question is whether sirolimus improves the overall response rate at 6 months compared with placebo. Primary outcome: \- Overall response rate at 6 months Secondary outcomes: * Overall response rate at 1 month and 3 months * Complete response rate at 6 months * Partial response rate at 6 months * Change in an

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (30-100ร—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\<3.0ร—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
๐Ÿ’Š

What it tests

  • Sirolimus
  • Placebo
๐Ÿ“

Where

10 sites
Xiangya Hospital of Central South University
Changsha, China
Qilu Hospital of Shandong University
Jinan, China
West China Hospital, Sichuan University
Chengdu, China
People's Hospital of Xinjiang Uygur Autonomous Region
รœrรผmqi, China
The 1st Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Beijing Chao-Yang Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China

โ€ฆand 2 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy