A Study on Factors of Biochemical Response in Autoimmune Hepatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Autoimmune Hepatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis
Overview
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.
Primary outcome measures
- Alanine aminotransferase (ALT) recovery [Time frame: From time of enrollment to the date of first ALT recovery, assessed up to 120 months]
- Aspartate transaminase (AST) recovery [Time frame: From time of enrollment to the date of first AST recovery, assessed up to 120 months]
- Immunoglobulin G (IgG) recovery [Time frame: From time of enrollment to the date of first IgG recovery, assessed up to 120 months]
- Death [Time frame: From time of enrollment to the date of death from liver disease, assessed up to 120 months]
- Liver transplantaiton [Time frame: From time of enrollment to the date of liver transplantation, assessed up to 120 months]
- Progression to hepatocellular carcinoma (HCC) [Time frame: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months]
Eligibility criteria
Inclusion criteria
- ≥18 years old at the time of onset;
- AIH simplified score ≥6 and/or AIH revised score ≥10;
- Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
- Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
- Agree to participate in this study and sign the informed consent form.
Exclusion criteria
- concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
- concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
- bone marrow or liver transplantation;
- incomplete baseline medical history and laboratory examination results;
- for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
- Pregnancy or lactation;
- patients with contraindications to glucocorticoid/immunosuppressive therapy;
- complicated with other malignant tumors;
- complicated with mental disorders.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Friendship Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT06356506 · 2022-P2-338-01