Observational study on autoimmune hepatitis in China
Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
This study looks at the experiences and long-term health of people with autoimmune hepatitis in China to see how well different treatments work and what factors affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05785793 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 14 years and older with a confirmed diagnosis of autoimmune hepatitis.
Not a fit: Patients with concurrent liver diseases or active infections that complicate the diagnosis of AIH may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and management of autoimmune hepatitis, leading to better patient outcomes.
How similar studies have performed: While there is limited data on similar cohort studies in China, the approach of evaluating real-world treatment effectiveness has shown promise in other regions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.