Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT05925023

Sirolimus in the Treatment of Refractory/Relapsed wAIHA

Led by Peking Union Medical College Hospital · Updated on 2025-08-08

22

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment. However, the recurrence rate is very high and some patients may not respond to steroids. Second-line therapies include cyclosporine A (CsA), cyclophosphamide, rituximab, azathioprine, and even splenectomy. Our previous study of sirolimus in refractory/relapsed AIHA and ES found an effective rate of 80%. Therefore, the investigators plan to explore the efficacy and safety of sirolimus in the treatment of refractory/relapsed wAIHA.

CONDITIONS

Official Title

Sirolimus in the Treatment of Refractory/Relapsed wAIHA

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with primary warm autoimmune hemolytic anemia or Evans syndrome (primary or secondary)
  • No active systemic treatment indication for other diseases if secondary Evans syndrome
  • No response to glucocorticoid therapy or relapse after treatment
  • Baseline liver enzymes (ALT, AST) less than twice the normal value
  • No active infection
  • Not pregnant or breastfeeding
  • Signed consent form
Not Eligible

You will not qualify if you...

  • Connective tissue disease or involvement of other organs
  • Infection or bleeding not controlled by standard treatment
  • Active HIV, HCV, or HBV infection, cirrhosis, or portal hypertension
  • Uncontrolled progressing malignant tumors or lymphoma
  • Cirrhosis or portal hypertension
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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