Methylation patterns and risk prediction for hepatitis B–related acute-on‑chronic liver failure
Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure
Qilu Hospital of Shandong University · NCT07275554
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University (other) |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT07275554 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Yu-Chen Fan
- Email: fanyuchen@sdu.edu.cn
- Phone: 0086+053182169593
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HBV Related Acute-on-chronic Liver Failure, HBV-related Liver Cirrhosis, HBV