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Recruiting

NCT Number: NCT06779864

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

Location contact

Xiaoning Wu, Dr.

CONTACT

[email protected]

86+(010)6313-86686

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaoning Wu

CONTACT

[email protected]

86+(010)6313-8665

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Acronym: HBV IMDR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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