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RECRUITING
NCT06874127

Non-Invasive Model for Fibrosis Regression in HBV Patients

Sponsor: Beijing Friendship Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1100

Start Date

2024-02-01

Completion Date

2026-05-01

Last Updated

2025-03-13

Healthy Volunteers

No

Interventions

DRUG

Nucleos(t)ide Analogs (NA)

all patients received NAs

Locations (1)

Beijing Friendship Hospital

Beijing, China