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

NCT07275554 | Recruiting DMC

• 1 other identifier: KYLL-202410-059-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Analysis of Methylomic Features in Patients with Hepatitis B-Related Acute-on-Chronic Liver Failure

  48months

Study Arms (3)

Chronic hepatitis B

Hepatitis B-related liver cirrhosis

Hepatitis B-related acute-on-chronic liver failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients with chronic hepatitis B, Hepatitis B-related liver cirrhosis, and Hepatitis B-related acute-on-chronic liver failure

You may qualify if:

• 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 \[International Normalized Ratio (INR) ≥ 1.5 or Prothrombin Activity (PTA) \< 40%\].

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Yu-Chen Fan

CONTACT

0086+053182169593; fanyuchen@sdu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-03

Locations

CN (1)