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Study of the Clinical Features of Autoimmune Hepatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02994537
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : November 24, 2020
West China Hospital
Information provided by (Responsible Party):
Li Yang, West China Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Hepatitis, Autoimmune Other: Different biochemical results or pathogenesis.

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Clinical Features of Autoimmune Hepatitis
Study Start Date : October 2013
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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.

Biospecimen Retention:   Samples Without DNA
serum and or liver tissue

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients from the hospital outpatient or inpatient department, there is no geographical restrictions.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02994537

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Contact: Li Yang, MD +86 18980601276
Contact: Yi Shen, MD +86 18280097412 ext 13547007135

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China, Sichuan
Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Li Yang, MD    +86 18980601276   
Contact: Yi Shen, MM    +86 18280097412   
Principal Investigator: Yi Shen, MM         
Sponsors and Collaborators
Li Yang
West China Hospital
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Study Director: Li Yang, MD Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Li Yang, MD, West China Hospital Identifier: NCT02994537    
Other Study ID Numbers: AAIH-001
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators need to discuss with other participants whether or not to share data of the study.
Keywords provided by Li Yang, West China Hospital:
autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases