Methylation patterns and risk prediction for hepatitis B–related acute-on‑chronic liver failure
Official title: Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure
Run by Qilu Hospital of Shandong University · NCT07275554 · Data updated 2026-11-12
This project will test whether methylation patterns can predict outcomes for people with hepatitis B–related acute-on‑chronic liver failure or cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Status | Recruiting |
| Started | December 31, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07275554 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic hepatitis B who meet the 2018 Asia‑Pacific criteria for HBV-related acute-on‑chronic liver failure or who have HBV-related cirrhosis and can provide required clinical data at Qilu Hospital are ideal candidates.
✕Probably not a fit
Patients with co-infection by other hepatitis viruses, autoimmune liver disease, prior malignancy, inadequate clinical data, or non-HBV causes of liver failure are unlikely to benefit from this specific methylomics-based model.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational effort will enroll patients with chronic hepatitis B who have HBV-related acute-on‑chronic liver failure or HBV-related cirrhosis at Qilu Hospital and collect clinical data and biosamples. Genome-wide DNA methylation (methylomics) profiling will be performed to identify methylation features linked to prognosis. The team will build and validate a prognostic risk-prediction classifier based on those methylation signatures. The aim is to develop a methylomics-based tool to support clinical assessment and improve diagnostic and prognostic efficiency for liver failure.
Why it matters
Potential benefit: If successful, this could give clinicians a more accurate way to predict outcomes and tailor treatment for patients with HBV-related liver failure.
How similar studies have gone: Some prior work has identified methylation biomarkers linked to liver disease progression, but methylomics-based prognostic models specifically for HBV-related ACLF are novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Qilu Hospital of Shandong University
Jinan, Shandong, China Recruiting
Study contacts
- Study coordinator: Yu-Chen Fan
- Email: fanyuchen@sdu.edu.cn
- Phone: 0086+053182169593
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Risk prediction for HBV-related liver cancer
This project tests an AI-based follow-up system to try to improve early detection of liver cancer in people with chronic hepatitis B and related risk factors.
-
Immune changes over time in people with chronic hepatitis B
This project will follow untreated people aged 1–80 with chronic hepatitis B every six months to see if changes in HBV-specific immunity and age are linked to how the infection progresses.
-
Triple HIV/HBV/HCV screening alert in primary care
Doctors in primary care will test a new EMR alert that suggests screening for HIV, HBV, and HCV when ordering blood tests for adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.