Actively Recruiting
Clinical Characteristics and Outcomes of Autoimmune Hepatitis: a Retro-prospective Multicenter Cohort in China
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2023-03-28
1000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying autoimmune hepatitis (AIH), a chronic liver disease that causes inflammation and can lead to cirrhosis and liver failure. This observational study is focused on patients in China, aiming to describe the clinical features, long-term prognosis, and the effectiveness and safety of various AIH treatments in real-world settings. The study addresses the growing prevalence of AIH in China and the challenges in diagnosing and managing this condition due to its variable presentation and outcomes. The study collects data from about 20 sites across China, monitoring patients receiving different AIH treatments including standard therapies as well as second- and third-line options. Researchers track treatment progress, responses, and any adverse effects over time. There is no intervention assigned by the study; instead, it observes routine clinical care and treatment choices made by healthcare providers. Participants will be followed for up to 60 months from the baseline to record outcomes such as transplant-free survival, liver-related death, biochemical response, remission status, and complications. Data collection includes clinical evaluations and laboratory tests essential for diagnosis and monitoring. The study aims to identify risk factors influencing long-term outcomes to improve AIH diagnosis, treatment, and management for patients in China.
CONDITIONS
Brief Title
Autoimmune Hepatitis Cohort in China
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older
- Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria
- Availability of essential laboratory parameters at initial AIH diagnosis, including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin G, and platelet count
- Provide informed consent
You will not qualify if you...
- Diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, or immunoglobulin G 4-related cholangitis
- Active infection with hepatitis B virus, hepatitis C virus, hepatitis delta virus, HIV, cytomegalovirus, or Epstein-Barr virus
- Diagnosis of hepatocellular carcinoma or other malignant diseases before AIH diagnosis
- Considered ineligible for enrollment by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 60 months
Participants are observed over time to track disease progression, treatment effectiveness, and long-term outcomes.
Regular visits as part of routine clinical care
Trial Site Locations
Total: 1 location
1
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200001
Actively Recruiting
Research Team
X
Xiao Xiao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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