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NCT07518277: sirolimus

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

Not yet recruiting NA Last updated 8 April 2026
What this trial tests

NA trial testing Glucocorticoids in Autoimmune Hemolytic Anemia (AIHA) in 216 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
1 April 2028
1 April 2028

Quick facts

Lead sponsorChen Miao
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment216
Start date1 April 2026
Primary completion1 April 2028
Estimated completion1 April 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Chen Miao

Who can join

Adults 18 to 75, any sex, with Autoimmune Hemolytic Anemia (AIHA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Glucocorticoids

Trials testing the same drug.

Other recruiting trials for Autoimmune Hemolytic Anemia (AIHA)

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07518277.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing