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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Friendship Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2034

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2034

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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