NCT06874127

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,100 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Hepatitis B Virus (HBV) Infection
• Liver Fibrosis

Interventions

Type	Name	Description
DRUG	Nucleos(t)ide Analogs (NA)	all patients received NAs

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2026-05-01
• First posted: 2025-03-13
• Last updated: 2025-03-13

Locations

1 site across 1 country: China