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Real-World Observational Study on Autoimmune Hepatitis-Related Decompensated Cirrhosis

Real-World Observational Study on Autoimmune Hepatitis-Related Decompensated Cirrhosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118497
Enrollment
Unknown
Registered
2026-02-06
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hepatitis-related Decompensated Liver Cirrhosis

Interventions

Glucocorticoid Treatment Group:None
Non-Glucocorticoid Treatment Group:None

Sponsors

The Fifth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

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

MeasureTime 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

MeasureTime frame
Transplant-free survival rate within 2 years after treatment initiation.;Recompensation incidence within 2 years after treatment initiation.;

Countries

China

Contacts

Public ContactYing Sun

The Fifth Medical Center of PLA General Hospital

sunying_302@163.com+86 138 1054 5637

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026