Autoimmune Hepatitis Cohort in China

Last updated: March 26, 2023
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT05785793
AIH-CH
  • Ages > 14
  • All Genders

Study 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

Inclusion Criteria:

  • Age ≥ 14 years
  • Probable or definite diagnosis of autoimmune hepatitis according to the InternationalAutoimmune Hepatitis Study Group criteria
  • Availability of all following essential parameters at the initial diagnosis of AIH:including alanine transaminase, aspartate aminotransferase, total bilirubin, alkalinephosphatase, immunoglobulin G, and platelet count
  • Provide informed consent

Exclusion

Exclusion Criteria:

  • Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosingcholangitis, immunoglobulin G 4-related cholangitis
  • Have an active infection with hepatitis B virus, hepatitis C virus, hepatitis deltavirus, HIV, cytomegalovirus, or Epstein-Barr virus
  • Have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseasesbefore the diagnosis of AIH
  • Considered ineligible to the enrollment in the clinical study by the researcher

Study Design

Total Participants: 1000
Study Start date:
February 01, 2023
Estimated Completion Date:
February 01, 2028

Study Description

Autoimmune hepatitis (AIH) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. Although relatively rare, the prevalence of AIH in China has been increasing in recent years, highlighting its significance as a public health issue. However, due to the wide variability in the clinical presentation and outcomes of AIH, diagnosing and managing the disease can be challenging. Moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of AIH in China is still limited.

To address this gap in knowledge, the investigators are conducting the Chinese AIH Cohort study, which collects data from approximately 20 sites across China on treatment progress and success in clinical routine. The study aims to evaluate the effectiveness and safety/tolerability of different AIH treatment options, including standard therapy, and second and third-line treatment options. The investigators also record the long-term prognosis of patients with AIH, tracking whether they achieve remission, require liver transplantation, or experience mortality. Risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of AIH in this population.

Connect with a study center

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai 200001
    China

    Active - Recruiting

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