A Study on Factors of Biochemical Response in Autoimmune Hepatitis

April 18, 2024 updated by: Zhao Xinyan, Beijing Friendship Hospital

A Multicenter, Prospective Cohort Study on the Influencing Factors of Biochemical Response in Autoimmune Hepatitis

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

630

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100050
        • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Validation group
Validation group is used to validate the predictive model externally.
Modeling group
The data of modeling group is used to construct a predictive model of AIH end-point events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine aminotransferase (ALT) recovery
Time Frame: From time of enrollment to the date of first ALT recovery, assessed up to 120 months
Normalization of ALT
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
Normalization of AST
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
Normalization of IgG
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
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
Time Frame: From time of enrollment to the date of liver transplantation, assessed up to 120 months
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)
Time Frame: 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
From time of enrollment to the first date of HCC diagnosed, assessed up to 120 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Investigators

  • Study Chair: Xinyan Zhao, Beijing Friendship Hospital
  • Study Chair: Zhengsheng Zou, Beijing 302 Hospital
  • Principal Investigator: Yu Chen, Beijing You 'an Hospital, Capital Medical University
  • Principal Investigator: Pingying Li, Qinghai People's Hospital
  • Principal Investigator: Jia Li, Tianjin Second People's Hospital
  • Principal Investigator: Jingshou Chen, The First Affiliated Hospital of Xiamen University
  • Principal Investigator: Liang Wang, The Second Hospital of Lanzhou University
  • Principal Investigator: Huahua Wang, Jiaozuo People's Hospital
  • Principal Investigator: Xiaoli Hu, Heilongjiang Provincinal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2034

Study Completion (Estimated)

May 1, 2034

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

April 7, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-P2-338-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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