A Study on Factors of Biochemical Response in Autoimmune Hepatitis (NCT06356506) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study on Factors of Biochemical Response in Autoimmune Hepatitis
China630 participantsStarted 2024-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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;
What they're measuring
1
Alanine aminotransferase (ALT) recovery
Timeframe: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
2
Aspartate transaminase (AST) recovery
Timeframe: From time of enrollment to the date of first AST recovery, assessed up to 120 months
3
Immunoglobulin G (IgG) recovery
Timeframe: From time of enrollment to the date of first IgG recovery, assessed up to 120 months
4
Death
Timeframe: From time of enrollment to the date of death from liver disease, assessed up to 120 months
5
Liver transplantaiton
Timeframe: From time of enrollment to the date of liver transplantation, assessed up to 120 months
6
Progression to hepatocellular carcinoma (HCC)
Timeframe: From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months