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

NCT ID: NCT07275554

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chronic hepatitis B

No interventions assigned to this group

Hepatitis B-related liver cirrhosis

No interventions assigned to this group

Hepatitis B-related acute-on-chronic liver failure

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu-Chen Fan

Role: CONTACT

0086+053182169593

Facility Contacts

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Yu-Chen Fan

Role: primary

0086+053182169596

Other Identifiers

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KYLL-202410-059-1

Identifier Type: -

Identifier Source: org_study_id

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