Autoimmune Hepatitis
Conditions
Keywords
Autoimmune hepatitis, Biochemical response, Prognosis, Immunosuppressive therapy
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Beijing Friendship Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alanine aminotransferase (ALT) recovery | From time of enrollment to the date of first ALT recovery, assessed up to 120 months | Normalization of ALT |
| Aspartate transaminase (AST) recovery | From time of enrollment to the date of first AST recovery, assessed up to 120 months | Normalization of AST |
| Immunoglobulin G (IgG) recovery | From time of enrollment to the date of first IgG recovery, assessed up to 120 months | Normalization of IgG |
| Death | From time of enrollment to the date of death from liver disease, assessed up to 120 months | Patients die because of liver diseases |
| Liver transplantaiton | From time of enrollment to the date of liver transplantation, assessed up to 120 months | Patients have liver transplantation because of AIH |
| Progression to hepatocellular carcinoma (HCC) | From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months | Patients progress to hepatocellular carcinoma due to poor treatment response |
Countries
China
Contacts
Primary ContactYu Su
Backup ContactQianyi Wang
Outcome results
None listed