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

NCT ID: NCT06779864

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-01

Study Completion Date

2026-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Antiviral treatment chronic hepatitis B cohort

No interventions assigned to this group

Hepatitis B patients in cross-sectional epidemiological survey cohort

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hong You

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaoning Wu

Role: CONTACT

86+(010)6313-8665

Facility Contacts

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Xiaoning Wu, Dr.

Role: primary

86+(010)6313-86686

Other Identifiers

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2023YFC2306903

Identifier Type: -

Identifier Source: org_study_id

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