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

November 27, 2025 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Yu-Chen Fan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic hepatitis B
Hepatitis B-related liver cirrhosis
Hepatitis B-related acute-on-chronic liver failure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Analysis of Methylomic Features in Patients with Hepatitis B-Related Acute-on-Chronic Liver Failure
Time Frame: 48months
48months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202410-059-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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