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

NCT06779864 | Recruiting

• 1 other identifier: 2023YFC2306903
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Keywords

HBV; HBV Mutation; HBV Integration; HBV Resistance

Outcome Measures

Primary Outcomes (1)

• Changes in hepatitis B virus integration sites and count under antiviral treatment

  Testing of previously collected samples within the time frame of 2015 to 2023

Secondary Outcomes (3)

• Hepatitis B virus variants related to drug resistance under antiviral treatment

  Testing 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 progression

  Testing of previously collected samples within the time frame of 2015 to 2023

Study Arms (2)

Antiviral treatment chronic hepatitis B cohort

Hepatitis B patients in cross-sectional epidemiological survey cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with hepatitis B surface antigen positive.
• Patients who have complete demographic information, clinical data and retained blood samples or liver tissue samples

You may not qualify if:

• Subject who without blood samples or liver tissue samples

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum; Plasma

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaoning Wu

CONTACT

86+(010)6313-8665; byfriendship145@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 17, 2025
• Study Start: February 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)