A Study on Factors of Biochemical Response in Autoimmune Hepatitis

Launched by BEIJING FRIENDSHIP HOSPITAL · Apr 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying autoimmune hepatitis (AIH), a condition where the body’s immune system attacks the liver. Researchers want to understand more about how certain genetic factors may affect the disease in Chinese patients and what might influence their response to treatment. The goal is to gather important information about patients' liver health and their treatment experiences over time.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of AIH that meets specific scoring criteria. They should not have other liver diseases or be undergoing certain treatments. Participants will need to provide liver test results and treatment details during the study. This trial is currently not recruiting participants, but it aims to improve understanding of AIH and help doctors better care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. ≥18 years old at the time of onset;
• • 2. AIH simplified score ≥6 and/or AIH revised score ≥10;
• • 3. Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
• • 4. Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
• • 5. Agree to participate in this study and sign the informed consent form.
• Exclusion Criteria:
• • 1. concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
• • 2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
• • 3. bone marrow or liver transplantation;
• • 4. incomplete baseline medical history and laboratory examination results;
• • 5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
• • 6. Pregnancy or lactation;
• • 7. patients with contraindications to glucocorticoid/immunosuppressive therapy;
• • 8. complicated with other malignant tumors;
• • 9. complicated with mental disorders.