Non-Invasive Model for Fibrosis Regression in HBV Patients
Recruiting now
Conditions studied: Chronic Hepatitis B Virus (HBV) Infection, Liver Fibrosis
In brief
A total of 1000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are retrospectively enrolled. All the patients received NAs treatment. Blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers were collected. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death were collected. Fibrosis regression prediction model based on dynamic changes in liver stiffness will be developed based on the retrospective cohort. An independent cohort of CHB patients with liver biopsy performed at least 1 year after antiviral therapy will be retrospectively enrolled for model validation.
Key facts
- Study ID
- NCT06874127
- Run by
- Beijing Friendship Hospital
- People needed
- 1100
- Starts
- 2024-02-01
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2025-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Beijing Friendship Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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