Could a transplant drug tame stubborn low platelets in antiphospholipid syndrome?
NCT ID NCT06722586
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This trial tests whether sirolimus (rapamycin), an immune-suppressing drug, can safely raise platelet counts in people with antiphospholipid antibodies and persistent low platelets. Participants are randomly assigned to receive sirolimus or a placebo for six months, and those who do not respond may receive sirolimus for an additional three months. The main goal is to see if sirolimus leads to a meaningful increase in platelet levels compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sirolimus (rapamycin)
- What this could lead to
- If it works, sirolimus could offer a new, steroid-sparing option to manage low platelet counts in people with antiphospholipid antibodies.
- What could go wrong
- This is a Phase 4 trial with 84 participants. Sirolimus may not improve platelet counts more than placebo, and side effects like mouth sores, infections, or high cholesterol are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 84 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2025
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Antiphospholipid (APL)-positive are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
10 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Beijing Chao-Yang Hospital
RECRUITINGBeijing, 100020, China
-
Beijing Shijitan Hospital
RECRUITINGBeijing, China
-
Peking University First Hospital
RECRUITINGBeijing, 100034, China
-
Peking University Third Hospital
RECRUITINGBeijing, 100083, China
-
People's Hospital of Xinjiang Uygur Autonomous Region
RECRUITINGÜrümqi, Xinjiang, 830001, China
-
Qilu Hospital of Shandong University
RECRUITINGJinan, Shangdong, 250012, China
-
Shanghai Renji Hospital
RECRUITINGShanghai, 200001, China
-
The 1st Affiliated Hospital of Wenzhou Medical University
RECRUITINGWenzhou, Zhejiang, 325015, China
-
West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, 610041, China
-
Xiangya Hospital of Central South University
RECRUITINGChangsha, Hunan, 410013, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.