RecruitingNCT06874127

Non-Invasive Model for Fibrosis Regression in HBV Patients

Establishment and Application of a Non-Invasive Dynamic Model for Fibrosis Regression in Patients with Chronic Hepatitis B

Sponsor

Beijing Friendship Hospital

Enrollment

1,100 participants

Start Date

Feb 1, 2024

Study Type

OBSERVATIONAL

Conditions

Chronic Hepatitis B Virus (HBV) Infection Liver Fibrosis

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a non-invasive way to predict whether liver scarring (fibrosis) is improving in people with chronic Hepatitis B who have been on antiviral medication — without needing repeated liver biopsies. **You may be eligible if...** - You have chronic Hepatitis B and have been on antiviral treatment - You have had a liver biopsy at least 1 year after starting antiviral therapy - You have records of liver stiffness testing or a specific blood ratio (APRI) from before your antiviral treatment began **You may NOT be eligible if...** - You have advanced liver complications (such as fluid in the abdomen, liver failure, or bleeding from the esophagus) - You have had liver cancer or a liver transplant - You also have Hepatitis C, HIV, alcoholic liver disease, or another type of liver disease - You have other unrelated cancers or serious heart, lung, brain, kidney, or blood conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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