A Study on Factors of Biochemical Response in Autoimmune Hepatitis

Not yet recruiting

• Conditions: Autoimmune Hepatitis

• Registration Number: NCT06356506
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Study First Submitted: 2024-01-22
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-07
• Study First Posted: 2024-04-10
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Study Start: 2024-05-01
• Primary Completion: 2034-05-01
• Study Completion: 2034-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 630

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Liver transplantaiton	From time of enrollment to the date of liver transplantation, assessed up to 120 months	Patients have liver transplantation because of AIH
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
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

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China