Clinical Trial

New HBV Infection Biomarkers: Clinical Characterization and Impact on Management

Study acronym: HBV-Biomark
Recruiting
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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.
Trial Details
NCT Number NCT06906016
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Chronic Hepatitis B Virus (HBV) Infection
Enrollment 900 participants
Start Date 2023-11-28
Primary Completion 2038-11-27 (estimated)
Study Completion 2038-11-27 (estimated)
Updated on ClinicalTrials.gov 2025-04-02