Not Yet RecruitingNot Applicable

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

China216 participantsStarted 2026-04-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥18 years old, gender not limited;
✓. Diagnosed as newly diagnosed wAIHA and requiring systemic immunosuppressive therapy (those with short-term hormone exposure of ≤2 weeks before enrollment can be included)
✓. After a comprehensive rheumatology and immunology assessment, there is no evidence of clinical organ involvement in SLE or other connective tissue diseases (only serological abnormalities can be included).
✓. Positive Coombs test (IgG type, IgG+C3d type, or only C3d type with a condensed agglutinin titer of 1:64);
✓. Active hemolytic anemia, hemoglobin (HGB) ≤ 100 g/L;
✓. Liver and kidney function: Alanine aminotransferase (ALT) \< 3 times the upper limit of the normal value (ULN), isolated elevation of aspartate aminotransferase (AST) (normal ALT) is acceptable; Serum creatinine ≤2×ULN;
✓. Eastern Cooperative Oncology Group (ECOG) Performance status score ≤2 points;
✓. Those with a history of malignant tumors must meet the following conditions:

Exclusion criteria

What they're measuring

The 12-month sustained remission rate

Timeframe: 12 months

Trial details

NCT IDNCT07518277

SponsorChen Miao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04-01

View on ClinicalTrials.gov More Autoimmune Hemolytic Anemia (AIHA) trials