Autoimmune Hepatitis-related Decompensated Liver Cirrhosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) All patients were diagnosed with autoimmune hepatitis (AIH) according to the simplified diagnostic criteria or the comprehensive diagnostic scoring system for AIH. 2) Imaging evidence (ultrasound, MRI, CT, etc.) confirmed the presence of liver cirrhosis 3) Decompensated complications were present, including ascites, gastrointestinal bleeding, sepsis, hepatic encephalopathy, or hepatorenal syndrome. 4) Age ranged from 18 to 80 years. 5) Written informed consent was provided by all participants.
Exclusion criteria
Exclusion criteria: 1) Patients with concurrent liver diseases including primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), hepatitis virus infection, alcoholic liver disease, drug-induced liver injury, hepatocellular carcinoma, or a history of liver transplantation. 2) Patients with severe heart disease, chronic kidney disease, malignancies, or other major extrahepatic chronic illnesses significantly affecting life expectancy. 3) Patients with a history of prior immunosuppressive agent use. 4) Pregnant or lactating women. 5) Patients who had received regular glucocorticoid therapy before the onset of decompensated autoimmune hepatitis-related cirrhosis. 6) Patients with conditions contraindicated to or intolerant of glucocorticoid therapy, including osteoporosis, active peptic ulcer disease, psychiatric disorders, severe infection, uncontrolled hypertension, and uncontrolled diabetes mellitus. 7) Patients with overt hepatic encephalopathy. 8) Patients unable to comply with follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whether aminotransferase and IgG levels can normalize within 6 months after treatment initiation.;Whether aminotransferase and IgG levels can normalize within 12 months after treatment initiation.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Transplant-free survival rate within 2 years after treatment initiation.;Recompensation incidence within 2 years after treatment initiation.; | — |
Countries
China
Contacts
The Fifth Medical Center of PLA General Hospital