Observational study on autoimmune hepatitis in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to describe the clinical features and long-term prognosis of patients diagnosed with autoimmune hepatitis (AIH) in China. It will collect data from approximately 20 sites across the country to assess the effectiveness and safety of various AIH treatment options in a real-world setting. The study will track treatment progress, remission rates, and long-term outcomes such as the need for liver transplantation or mortality. Additionally, it will analyze risk factors associated with prognosis to enhance the management of AIH.

Why it matters

Who can join: the full rules

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

Where it's running

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Xiao Xiao, MD
• Email: xiaoxiao@renji.com
• Phone: 021-68383104

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.