Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis B. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Changes in hepatitis B virus integration sites and count under antiviral treatment [Time frame: Testing of previously collected samples within the time frame of 2015 to 2023]
Secondary outcome measures (3)
- Hepatitis B virus variants related to drug resistance under antiviral treatment [Time frame: Testing of previously collected samples within the time frame of 2015 to 2023]
- Genetic mutations in Hepatitis B virus across different regions and populations. [Time frame: 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 [Time frame: Testing of previously collected samples within the time frame of 2015 to 2023]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Beijing Friendship Hospital — Beijing
Identifiers
NCT: NCT06779864 · 2023YFC2306903