Condition: Antiphospholipid (aPL)-Positive · Thrombocytopaenia · Sponsor: Peking University First Hospital
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 anti-phospholipid antibody titers at 6 months * Change in oral glucocorticoid dosage at 6 months Exploratory outcomes: * Proportion and reasons for early discontinuation during the double-blind phase * Among participants who do not achieve the primary endpoint at 6 months and enter the open-label extension, overall response rate, complete response rate, partial response rate, and safety outcomes after 3 months of open-label treatment
This description comes directly from the study's public registry record.
Lanlan Ji · +86-010-83575130 · thigh0829@163.com
Always discuss trial participation with your own doctor first.
| 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 |
| Peking University First Hospital | Beijing, China | Recruiting |
| Peking University Third Hospital | Beijing, China | Recruiting |
| Beijing Shijitan Hospital | Beijing, China | Recruiting |
| Shanghai Renji Hospital | Shanghai, China | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06722586