Skip to content

Study of the Clinical Features of Autoimmune Hepatitis

Study of the Clinical Features of Autoimmune Hepatitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02994537
Enrollment
500
Registered
2016-12-16
Start date
2013-10-31
Completion date
2022-12-31
Last updated
2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis, Autoimmune

Keywords

autoimmune hepatitis, diagnosis, pathogenesis, treatment, prognosis

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.

Interventions

OTHERDifferent 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.

Sponsors

West China Hospital
CollaboratorOTHER
Li Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Biochemical remission of participants3 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.

Countries

China

Contacts

Primary ContactLi Yang, MD
yangli_hx@scu.edu.cn+86 18980601276
Backup ContactYi Shen, MD
156450779@qq.com+86 18280097412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026