A Study on Factors of Biochemical Response in Autoimmune Hepatitis

NCT06356506 | Not Yet Recruiting

• 1 other identifier: 2022-P2-338-01
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Keywords

Autoimmune hepatitis; Biochemical response; Prognosis; Immunosuppressive therapy

Outcome Measures

Primary Outcomes (6)

• Alanine aminotransferase (ALT) recovery

  Normalization of ALT

  From time of enrollment to the date of first ALT recovery, assessed up to 120 months

• Aspartate transaminase (AST) recovery

  Normalization of AST

  From time of enrollment to the date of first AST recovery, assessed up to 120 months

• Immunoglobulin G (IgG) recovery

  Normalization of IgG

  From time of enrollment to the date of first IgG recovery, assessed up to 120 months

• Death

  Patients die because of liver diseases

  From time of enrollment to the date of death from liver disease, assessed up to 120 months

• Liver transplantaiton

  Patients have liver transplantation because of AIH

  From time of enrollment to the date of liver transplantation, assessed up to 120 months

• Progression to hepatocellular carcinoma (HCC)

  Patients progress to hepatocellular carcinoma due to poor treatment response

  From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months

Study Arms (2)

Modeling group

The data of modeling group is used to construct a predictive model of AIH end-point events.

Validation group

Validation group is used to validate the predictive model externally.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

AIH patients who fulfilled the inclusion and exclusion criteria were enrolled in this study.

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, hemocyte, liver histopathology (if any)

MeSH Terms

Conditions

Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xinyan Zhao

  Beijing Friendship Hospital

  STUDY CHAIR

• Zhengsheng Zou

  Beijing 302 Hospital

  STUDY CHAIR

• Yu Chen

  Beijing You 'an Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

• Jia Li

  Tianjin Second People's Hospital

  PRINCIPAL INVESTIGATOR

• Jingshou Chen

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

• Liang Wang

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

• Huahua Wang

  Jiaozuo People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoli Hu

  Heilongjiang Provincinal Hospital

  PRINCIPAL INVESTIGATOR

• Pingying Li

  Qinghai People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Su

CONTACT

18810639513; suyu_7912@163.com

Qianyi Wang

CONTACT

18519667363; wangqy1001@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: April 10, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2034
• Study Completion (Estimated): May 1, 2034
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)