Clinical trial NCT02994537: Study of the Clinical Features of Autoimmune Hepatitis
Official title: Study of the Clinical Features of Autoimmune Hepatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis, Autoimmune
Keywords: autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
First posted: 2016-12-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the hospital outpatient or inpatient department, there is no geographical restrictions.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical remission of participants
timeFrame: 3 years after standard immunosuppressive treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
state: Sichuan
Study officials:
affiliation: Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University
name: Li Yang, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.