Clinical Trial

A Multicenter, Prospective, Randomized Controlled Study Comparing Glucocorticoid Combined With Sirolimus With Monotherapy of Glucocorticoid in the Treatment of Newly Diagnosed Mild Autoimmune Hemolytic Anemia

Study acronym: sirolimus
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This study is a prospective, multicenter, randomized controlled trial. A total of 216 adult patients with newly diagnosed wAIHA were planned to be included and randomly assigned in a 1:1 ratio to the experimental group (glucocorticoid combined with sirolimus) or the control group (glucocorticoid monotherapy). The initial dose of sirolimus in the experimental group was 1mg/d, adjusted according to the blood drug concentration. The target concentration was 4-12ng/mL, and the treatment course was 6 months. Both groups of hormones were gradually reduced according to the standard protocol. All patients were followed up for 24 months, and the differences between the two groups at endpoints such as the hormone-free sustained response rate at the 12th month were compared.
Trial Details
NCT Number NCT07518277
Lead Sponsor Chen Miao
Conditions Autoimmune Hemolytic Anemia (AIHA)
Enrollment 216 participants
Start Date 2026-04-01
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-08