Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance

Recruiting

• Conditions: Chronic Hepatitis B

• Registration Number: NCT06779864
• Lead Sponsor: Beijing Friendship Hospital

Brief Summary

Patients with a confirmed diagnosis of chronic hepatitis B (CHB) who have complete clinical data and retained blood or liver tissue samples will be enrolled. All patients will be grouped based on cohort sources: the Antiviral Treatment Cohort and the Cross-Sectional Epidemiological Survey Cohort.

Patients in the Antiviral Treatment Cohort have received antiviral treatment and are followed every six months. During follow-up, HBV-related endpoint events, including cirrhosis decompensations (such as ascites, esophageal variceal bleeding, and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death, will be collected.

In the Cross-Sectional Epidemiological Survey Cohort, clinical data will be collected at a single time point, with some patients not receiving antiviral treatment.

In both cohorts, retained blood and liver tissue samples will be used to further analyze HBV genotypes, viral integration, drug resistance, and the molecular characteristics of mutations.

Finally, a detailed description will be provided regarding the correlation between these HBV genetic molecular features and demographic distribution, clinical phases, and various clinical outcome events.

Detailed Description

To identify HBV genotypes, viral integration, drug resistance, and molecular characteristics of mutations associated with clinical immune phases and different clinical outcome events based on a representative hepatitis B clinical cohort.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-17
• Last Update Posted: 2025-01-17
• Primary Completion: 2025-12-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Patients with hepatitis B surface antigen positive.
• Patients who have complete demographic information, clinical data and retained blood samples or liver tissue samples

Exclusion Criteria

• Subject who without blood samples or liver tissue samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in hepatitis B virus integration sites and count under antiviral treatment	Testing of previously collected samples within the time frame of 2015 to 2023

Secondary Outcome Measures

Name	Time	Method
Hepatitis B virus variants related to drug resistance under antiviral treatment	Testing of previously collected samples within the time frame of 2015 to 2023
Genetic mutations in Hepatitis B virus across different regions and populations.	Testing of previously collected samples within the time frame of 2014 to 2023
Genetic mutations in Hepatitis B virus related to different stages of disease progression	Testing of previously collected samples within the time frame of 2015 to 2023

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China