Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance (HBV IMDR)

Capital Medical University

Status: Enrolling

Conditions: Chronic Hepatitis B

Study type: Observational

Funder types: Other

Identifiers

NCT06779864

2023YFC2306903

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,000 participants in 2 patient groups

Antiviral treatment chronic hepatitis B cohort

Hepatitis B patients in cross-sectional epidemiological survey cohort