Non-invasive approach to assess liver fibrosis in chronic hepatitis B patients
Establishment and Application of a Non-Invasive Dynamic Model for Fibrosis Regression in Patients with Chronic Hepatitis B
This study is testing a new way to see if liver stiffness measurements can help predict if liver damage improves in people with chronic hepatitis B who have been treated with antiviral therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06874127 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls 1000 patients with chronic hepatitis B who have undergone liver biopsy at least one year after receiving antiviral therapy. It collects various health metrics, including liver stiffness measurements and blood tests, to develop a predictive model for liver fibrosis regression. The study aims to validate this model using an independent cohort of patients with similar criteria. The focus is on understanding the relationship between liver stiffness and fibrosis regression in patients treated with nucleos(t)ide analogs.
Who should consider this trial
Good fit: Ideal candidates are chronic hepatitis B patients who have had a liver biopsy at least one year after antiviral therapy.
Not a fit: Patients with decompensated cirrhosis, hepatocellular carcinoma, or other significant liver diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for monitoring liver fibrosis regression in chronic hepatitis B patients, improving patient management.
How similar studies have performed: Other studies have shown promise in using non-invasive methods for assessing liver fibrosis, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with liver biopsy performed at least 1 year after antiviral therapy; * Patients with liver biopsy or liver stiffness or aspartate aminotransferase (AST)-to-platelet (PLT) ratio index (APRI) before antiviral treatment. Exclusion Criteria: * Patients with decompensated cirrhosis (including ascites, hepatic encephalopathy, esophageal varices bleeding, hepatorenal syndrome, spontaneous bacterial peritonitis, or other complications of decompensated cirrhosis), hepatocellular carcinoma, or liver transplantation before liver biopsy; * Patients with hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, or other chronic liver diseases; * Patients with malignant lesion on liver image; * Patients with other uncured malignant tumors; * Patients with severe heart, lung, kidney, brain, blood, neuropsychiatric or other organs diseases; * Pregnant or lactating women; * Patients with any other reasons not suitable for the study.
Where this trial is running
Beijing
- Beijing Friendship Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yameng Sun
- Email: sunyamenggo@163.com
- Phone: 0086-13810643902
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.