BridgeMD
New treatment option for Antiphospholipid (aPL)-Positive
Official title Sirolimus Monotherapy in the Treatment of Antiphospholipid Antibody Related Thrombocytopenia
ClinicalTrials.gov ID: NCT06722586
What this study is testing
What is Sirolimus?
Sirolimus is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for antiphospholipid (apl)-positive.
Also referred to as Rapamycin, mTOR inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- persistent positive of antiphospholipid antibody (either lupus anticoagulant, anti-cardiolipin antibody, or anti-b2GP1 antibody, at least two times...
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
- Jinan, Shangdong, China
- Chengdu, Sichuan, China
- Ürümqi, Xinjiang, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China; Jinan, Shangdong, China; Chengdu, Sichuan, China; Ürümqi, Xinjiang, China; Wenzhou, Zhejiang, China; Beijing, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.