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Real-World Study of Unexplained Liver Function Abnormalities Focused on Liver Immunity

Real-World Study of Unexplained Liver Function Abnormalities Focused on Liver Immunity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500110443
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Autoimmune hepatitis

Interventions

Group 1 (Patients with cholestatic liver disease):None
Group 2 (patients with metabolism-related fatty liver):None
Group 3(Patients with autoimmune hepatitis):None
Group 4 (Patients with viral hepatitis):None
Group 5 (Patients with hepatitis of other unknown causes, including genetic, metabolic, and unknown causes):None
Group 6 (patients with normal liver enzymes, requiring liver biopsy for various reasons):None

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Group I: Patients with cholestatic liver disease: (1) Age 18~70 years old (including 18 and 70 years old); (2) Elevated serum bilirubin levels; (3) Imaging examination suggests the presence of cholestasis or biliary tract dilatation; (4) Serum alkaline phosphatase (ALP) and ?-glutamyl transferase (GGT) levels were elevated; (5) Liver histology biopsy showed bile duct inflammation; (6) Other patients who may have cholestatic liver disease judged by the clinician to meet any of the above (1) can be enrolled; 2. Group 2: Metabolic-related fatty liver patients: based on liver biopsy histology or imaging or even blood biomarker examination suggesting the presence of fatty liver, and meeting one of the following three conditions: (1) Overweight/obesity: BMI>23kg/m^2; (2) Type 2 diabetes: The diagnostic criteria for type 2 diabetes include fasting blood glucose value greater than 70 mmol/L, random blood glucose value greater than 11.1 mmol/L, glucose load greater than 11.1 mmol/L after two hours, and accompanied by clinical symptoms of polydipsia, polyphagia, polyuria, and weight loss; (3) Metabolic dysfunction (presence of at least two risk factors for metabolic abnormalities): waist circumference: 90/80cm > males and females, respectively; Blood pressure > 130/85 mm Hg or on specific drug therapy; Plasma triglycerides >1.70 mmolL or treated with specific drugs; Plasma HDL-cholesterol: 40 mg/dL ( 2.5; plasma hypersensitive C-reactive protein level > 2 g/L; 3. Group 3: Patients with autoimmune hepatitis: (1) Age 18–70 years (inclusive of 18 and 70); (2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels; (3) Presence of one or more high-titer autoantibodies in the serum; (4) Increased IgG and/or gamma-globulin; (5) Liver histology showing moderate to severe interface hepatitis, lymphoplasmacytic infiltration in the portal and periportal areas, moderate lobular inflammation, or other specific types of AIH manifestations; (6) AIH simplified diagnostic score and comprehensive diagnostic score >10. Any patient meeting one of the above criteria (1) can be included in the group; 4. Group 4: Patients with viral hepatitis: (1) Age 18–70 years (inclusive); (2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels; (3) Presence of one or more high-titer virus-specific markers in serum, such as anti-HAV IgM (hepatitis A), HBsAg and HBV DNA (hepatitis B), HCV RNA (hepatitis C), HDV RNA and HBsAg (hepatitis D), anti-HEV IgM (hepatitis E); (4) Histological examination of the liver showing hepatocellular inflammation and necrosis, with viral inclusions visible in liver parenchyma, or chronic inflammatory changes such as liver fibrosis or cirrhosis. Patients meeting any of the above criteria (1) can be included in the group; 5. Group 5: Patients with hepatitis of other or unknown causes (including genetic, metabolic, and unknown causes):(1) Age 18 to 70 years (inclusive);(2) Elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.6. Group 6: Patients with normal liver enzymes who require liver bi

Exclusion criteria

Exclusion criteria: 1. Patients with combined liver diseases such as viral hepatitis, metabolic-associated fatty liver disease, Wilson's disease, etc.; 2. Pregnant or breastfeeding women, and patients planning to conceive in the near future; 3. Patients with a history of severe heart disease, including unstable or uncontrolled heart disease within the past 6 months; 4. Patients with a history of psychiatric disorders; 5. Patients with uncontrolled epilepsy; 6. Individuals who have not ceased alcohol or drug abuse; 7. Other conditions deemed unsuitable for enrollment by the attending physician.

Design outcomes

Primary

MeasureTime frame
Alkaline phosphatase;MRI Assessment;Transaminase;bilirubin;autoantibody detection;liver B-ultrasound;immunoglobulin levels;blood routine;stool routine;

Countries

China

Contacts

Public ContactMingqin Lu

The First Affiliated Hospital of Wenzhou Medical University

lmq0906@163.com+86 577 5557 8055

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026