Study of the Clinical Features of Autoimmune Hepatitis

Hepatitis, Autoimmune Clinical Trial

Official title:

Study of the Clinical Features of Autoimmune Hepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02994537
• Other study ID #: AAIH-001
• Status: Recruiting
• Start date: October 2013
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: West China Hospital
• Contact: Li Yang, MD
• Phone: +86 18980601276
• Email: yangli_hx[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

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.

Locations

Country	Name	City	State
China	Division of Gastroenterology & Hepatology,West China Hospital,Sichuan University	Chengdu	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Li Yang	West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.