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Recruiting NCT07275554

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HBV Related Acute-on-chronic Liver Failure, HBV-related Liver Cirrhosis, HBV (Hepatitis B Virus). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Analysis of Methylomic Features in Patients with Hepatitis B-Related Acute-on-Chronic Liver Failure [Time frame: 48months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Qilu Hospital of Shandong University — Jinan

Identifiers

NCT: NCT07275554 · KYLL-202410-059-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗