A Study on Factors of Biochemical Response in Autoimmune Hepatitis

A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis

The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:

Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up.

This study aims to establish a high-quality, standardized prospective cohort of AIH with regular follow-up, clarify the clinical characteristics of AIH in China, construct a prognostic model, and explore new serum markers or AIH gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of AIH in China.

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.