Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Transplant free survival | Time to the first occurrence of liver transplant or death from any cause | From baseline to 60 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Liver-related death | Time to the first occurrence of liver transplant or death from liver-related cause | From baseline to 60 months after baseline |
| Biochemical response | Proportion of patients who achieve complete biochemical response (normalisation of serum transaminases and immunoglobulin G below the ULN) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The patients diagnosed as AIH in medical centers and outpatient clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiao Xiao, MD | Contact | 021-68383104 | xiaoxiao@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiong Ma, MD,PHD | Renji Hospital, School of Medicine, Shanghai Jiao Tong University. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 200001 | China |
Not provided
| ID | Term |
|---|---|
| D019693 | Hepatitis, Autoimmune |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
blood samples and liver biopsy specimens
| From baseline to 60 months after baseline |
| Remission | Proportion of patients who achieve remission (hepatitis activity index<4/18) | From baseline to 60 months after baseline |
| Complications | Occurrence of variceal hemorrhage, ascites, jaundice, encephalopathy and hepatocellular carcinoma | From baseline to 60 months after baseline |
| D001327 |
| Autoimmune Diseases |
| D007154 | Immune System Diseases |