Study of the Clinical Features of Autoimmune Hepatitis

NCT02994537 | Unknown

• 1 other identifier: AAIH-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis, Autoimmune

Keywords

autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis

Outcome Measures

Primary Outcomes (1)

• Biochemical remission of participants

  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.

Study Arms (1)

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.

Interventions

Different biochemical results or pathogenesis. OTHER

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.

acute autoimmune hepatitis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Clinical diagnosis of autoimmune hepatitis

You may not qualify if:

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

Sponsors & Collaborators

• Li Yang: lead
• West China Hospital: collaborator

Study Sites (1)

Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (4)

• Kessler WR, Cummings OW, Eckert G, Chalasani N, Lumeng L, Kwo PY. Fulminant hepatic failure as the initial presentation of acute autoimmune hepatitis. Clin Gastroenterol Hepatol. 2004 Jul;2(7):625-31. doi: 10.1016/s1542-3565(04)00246-0.

  PMID: 15224287 BACKGROUND

• Fujiwara K, Nakano M, Yasui S, Okitsu K, Yonemitsu Y, Yokosuka O. Advanced histology and impaired liver regeneration are associated with disease severity in acute-onset autoimmune hepatitis. Histopathology. 2011 Apr;58(5):693-704. doi: 10.1111/j.1365-2559.2011.03790.x. Epub 2011 Mar 14.

  PMID: 21401703 RESULT

• Abe M, Hiasa Y, Masumoto T, Kumagi T, Akbar SM, Ninomiya T, Matsui H, Michitaka K, Horiike N, Onji M. Clinical characteristics of autoimmune hepatitis with histological features of acute hepatitis. Hepatol Res. 2001 Nov;21(3):213-219. doi: 10.1016/s1386-6346(01)00109-7.

  PMID: 11673106 RESULT

• Shen Y, Lu C, Men R, Liu J, Ye T, Yang L. Clinical and Pathological Characteristics of Autoimmune Hepatitis with Acute Presentation. Can J Gastroenterol Hepatol. 2018 Mar 18;2018:3513206. doi: 10.1155/2018/3513206. eCollection 2018.

  PMID: 29744332 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum and or liver tissue

MeSH Terms

Conditions

Hepatitis, Autoimmune; Disease

Condition Hierarchy (Ancestors)

Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Yang, MD

  Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University

  STUDY DIRECTOR

Central Study Contacts

Li Yang, MD

CONTACT

+86 18980601276; yangli_hx@scu.edu.cn

Yi Shen, MD

CONTACT

+86 18280097412; 156450779@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 16, 2016
• Study Start: October 1, 2013
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

CN (1)