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Recruiting NCT05785793

Autoimmune Hepatitis Cohort in China

Trial Parameters

Condition Autoimmune Hepatitis
Sponsor Shanghai Jiao Tong University School of Medicine
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 14 Years
Max Age N/A
Start Date 2023-02-01
Completion 2028-02-01

Brief Summary

The goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (AIH) in China and assess the effectiveness and safety of AIH treatment options in a real-world setting.

Eligibility Criteria

Inclusion Criteria: * Age ≥ 14 years * Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria * Availability of all following essential parameters at the initial diagnosis of AIH: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count * Provide informed consent Exclusion Criteria: * Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin G 4-related cholangitis * Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus * Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of AIH * Considered ineligible to the enrollment in the clinical study by the researcher

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