Study of the Clinical Features of Autoimmune Hepatitis

April 28, 2022 updated by: Li Yang
The purpose of this study is to explore the pathogenes, clinical characteristics, laboratory and histological examination results, treatment and prognosis of autoimmune hepatitis(AIH). At phase 1, the investigators focus on studying of the clinical characteristics of acute autoimmune hepatitis, and then will study the difference about treatment effects between acute autoimmune hepatitis and chronic AIH. Morever, the investigators have noticed that drug induced AIH have some special characteristics that may be beneficial to distinguish it with durg induced liver disease. Therefore the investigators will do some studies about drug induced AIH or other disease which maybe related to the onset of AIH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Now this study has been researched at phase 1, the investigators focus on studying the difference between acute AIH and chronic AIH. In this phase, the investigators analysed the serum biochemical results such as ALT,AST,IgG,PT,INR and so on, and also compared the histological performance. Finally, we compared the percentages of biochemical remission in the two groups, and the time from initial treatment to biochemical remission has also been put into the analysis. Now, the investigators are preparing for submitting the manuscript of phase 1.

Study Type

Observational

Enrollment (Anticipated)

500

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 Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Division of Gastroenterology & Hepatology,West China Hospital,Sichuan 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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from the hospital outpatient or inpatient department, there is no geographical restrictions.

Description

Inclusion Criteria:

  • Clinical diagnosis of autoimmune hepatitis

Exclusion Criteria:

  • Other causes of liver disease, such as viral hepatitis, drug induced liver disease, primary biliary cirrhosis, primary sclerosing cholangitis, overlap syndrome and so on.

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
Intervention / Treatment
acute autoimmune hepatitis
Patients diagnosed autoimmune hepatitis(AIH) are divided into acute cohort or chronic cohort (acute-on-chronic and chronic were all included)by biochemical results, such as liver function and coagulation, then the investigators will compare the histological results, treatment effects and prognosis between the two groups. Further more, the investigators will study the pathogenesis of different forms of autoimmune hepatitis. Even more, the investigators want to explore drug induced AIH and viral hepatitis related AIH.
Other: Different biochemical results or pathogenesis.
Comparing the pathogenesis,clinical characteristics and treatment effects between the acute autoimmune hepatitis group and the chronic autoimmune hepatitis group. The investigators don't use special intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical remission of participants
Time Frame: 3 years after standard immunosuppressive treatment.
This study is now in the phase 1, and the outcome at phase 1 is the biochemical remission of AIH patients. In details, if the participants' serum ALT,AST and IgG returned to normal, that means this participant reached the biochemical remission.
3 years after standard immunosuppressive treatment.

Collaborators and Investigators

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

Sponsor

Li Yang

Collaborators

West China Hospital

Investigators

  • Study Director: Li Yang, MD, Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (ESTIMATE)

December 16, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAIH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators need to discuss with other participants whether or not to share data of the study.

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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