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NOT YET RECRUITING
NCT07518277
NA

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

Sponsor: Chen Miao

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2026-04-01

Completion Date

2028-04-01

Last Updated

2026-04-08

Healthy Volunteers

No

Interventions

DRUG

Glucocorticoids

Glucocorticoids combined with sirolimus

Locations (1)

Peking union medical college hospital

Beijing, Shuangfuyuan, NO I., China