Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Shandong University

Status: Enrolling

Conditions: HBV Related Acute-on-chronic Liver Failure; HBV (Hepatitis B Virus); HBV-related Liver Cirrhosis

Study type: Observational

Funder types: Other

Identifiers

NCT07275554

KYLL-202410-059-1

Details and patient eligibility

About

This study aims to investigate the methylomic features of patients with hepatitis B-related acute-on-chronic liver failure and establish and validate a prognostic risk prediction classification model. The findings are of significant importance for guiding clinical practice and improving patient prognosis. Additionally, a methylomics-based classifier model for liver failure will be developed for disease prognosis analysis and clinical assessment, with the potential to enhance the diagnostic efficiency of liver failure.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B was persistent hepatitis B surface antigen (HBsAg) seropositivity for more than six months.

Hepatitis B-related liver cirrhosis was diagnosed based on histological examination, typical features on ultrasound or radiological imaging, endoscopic findings of portal hypertension, and clinical history.

Hepatitis B-related acute-on-chronic liver failure meets the diagnostic criteria of the 2018 Asia-Pacific guidelines for the diagnosis and treatment of liver failure.Laboratory tests:Jaundice: Serum total bilirubin ≥ 85 µmol/L and coagulopathy [International Normalized Ratio (INR) ≥ 1.5 or Prothrombin Activity (PTA) < 40%].

Exclusion criteria

• co-infection with other hepatitis viruses; history of hepatocellular carcinoma or other malignancies; concomitant autoimmune liver disease; or insufficient clinical data.

Trial design

100 participants in 3 patient groups

Chronic hepatitis B

Hepatitis B-related liver cirrhosis

Hepatitis B-related acute-on-chronic liver failure