MedTrace Logo

New HBV Infection Biomarkers: Clinical Characterization and Impact on Management

NCT06906016 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2025-04-02

No results posted yet for this study

Summary

Chronic Hepatitis B Virus (HBV) infection affects nearly 300 million people worldwide and is a leading cause of liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). In France, it affects around 0.3% of the population. Current clinical practice relies on traditional biomarkers, such as HBV DNA and HBsAg, to monitor viral replication and disease progression. However, these biomarkers do not fully capture the viral activity or predict clinical outcomes. Recently, new biomarkers like HBcrAg and HBV RNA have emerged, showing promise for better understanding the natural history of the infection and guiding treatment decisions. The main objective of this research is to evaluate the predictive role of these biomarkers (HBcrAg, HBV RNA) in HBV-infected patients, focusing on their association with HBsAg seroconversion and their ability to predict clinical events like cirrhosis and HCC. Secondary objectives include describing the clinicobiological characteristics of patients, determining HBV genotypes, characterizing the impact of HBV on the host's transcriptome, and studying the biomarkers' role in different phases of the infection and treatment. The ultimate goal is to identify more accurate biomarkers to guide antiviral treatment, predict disease progression, and potentially determine when treatment can be safely discontinued.

Conditions

  • Chronic Hepatitis B Virus (HBV) Infection

Interventions

BIOLOGICAL

Collection of blood samples for the study of HBV biomarkers

The intervention involves the additional and minimal collection of two blood samples during routine care procedures (9mL in a dry tube and 9mL in a Paxgene tube). These samples are specifically collected for research purposes and will be stored in the laboratory at the Henri Mondor Biobank Platform under the responsibility of Pr Bijan Ghaleh-Marzban for 15 years. The samples will be preserved under strict conditions and may be used for future analyses related to the pathology of HBV infection or other scientific advancements, with the patient's informed consent.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-28
Primary Completion
2038-11-27
Completion
2038-11-27

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906016 on ClinicalTrials.gov