Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06779864
Acronym
HBV IMDR
Enrollment
2000
Registered
2025-01-17
Start date
2024-02-01
Completion date
2026-11-30
Last updated
2025-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Keywords

HBV, HBV Mutation, HBV Integration, HBV Resistance

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.

Interventions

None listed

Sponsors

Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in hepatitis B virus integration sites and count under antiviral treatmentTesting of previously collected samples within the time frame of 2015 to 2023

Secondary

MeasureTime frame
Hepatitis B virus variants related to drug resistance under antiviral treatmentTesting 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 progressionTesting of previously collected samples within the time frame of 2015 to 2023

Countries

China

Contacts

Primary ContactXiaoning Wu
byfriendship145@163.com86+(010)6313-8665

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026