Clinical trial NCT06779864: Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
Official title: Molecular Characteristics of Hepatitis B Virus Integration, Mutation, and Drug Resistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis B
Keywords: HBV
HBV Mutation
HBV Integration
HBV Resistance
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatitis B surface antigen positive, who have complete clinical data and retained blood samples or liver tissue samples.

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.

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

Primary outcomes:
measure: Changes in hepatitis B virus integration sites and count under antiviral treatment
timeFrame: Testing of previously collected samples within the time frame of 2015 to 2023
Secondary outcomes:
measure: Hepatitis B virus variants related to drug resistance under antiviral treatment
timeFrame: Testing of previously collected samples within the time frame of 2015 to 2023
measure: Genetic mutations in Hepatitis B virus across different regions and populations.
timeFrame: Testing of previously collected samples within the time frame of 2014 to 2023
measure: Genetic mutations in Hepatitis B virus related to different stages of disease progression
timeFrame: Testing of previously collected samples within the time frame of 2015 to 2023
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
References: