Investigating risk factors for liver inflammation and fibrosis in patients with chronic hepatitis B and non-alcoholic fatty liver disease
Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With Chronic Hepatitis B Combined With Non-alcoholic Fatty Liver Disease
This study is trying to find out what factors can increase the risk of liver inflammation and scarring in people with chronic hepatitis B and non-alcoholic fatty liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT05766449 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the risk factors associated with hepatic inflammation and fibrosis in patients suffering from chronic hepatitis B (CHB) and non-alcoholic fatty liver disease (NAFLD). By utilizing a multicenter approach, the study will establish diagnostic models to better understand the progression of liver-related complications such as cirrhosis and liver cancer. The research will focus on identifying key indicators that predict the risk of severe liver conditions in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have a positive hepatitis B surface antigen for at least six months and have been diagnosed with NAFLD.
Not a fit: Patients with other chronic liver diseases, such as alcoholic liver disease or other viral hepatitis, or those with pre-existing liver cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic models and risk assessment tools for patients with chronic hepatitis B and NAFLD, potentially reducing the incidence of severe liver complications.
How similar studies have performed: While there have been studies investigating liver diseases, this specific approach focusing on the intersection of chronic hepatitis B and NAFLD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1.18 years or older 2. Positive hepatitis B surface antigen (HBsAg) for at least 6 months and without other viral co-infection at baseline 2.NAFLD diagnosed by imaging liver biopsy, and/or blood testing/predictive indices Exclusion Criteria: 1. Other chronic liver diseases, such as alcoholic liver disease, other viral hepatitis, drug-induced liver injury; 2. HCC or other malignancies before liver biopsy;
Where this trial is running
Nanjing
- Nanjing Drum Tower Hospital — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Jie Li, M.D., Ph.D
- Email: lijier@sina.com
- Phone: 15863787910
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.