New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
Recruiting · NCT06906016 · Observational (researchers observe without assigning treatment) · Lead sponsor: Assistance Publique - Hôpitaux de Paris
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 18 years old
- Chronic HBV infection (HbsAg positive carrier for more than 6 months)
- Patient under care within the Henri Mondor-Albert Chenevier University Hospital group
Exclusion criteria
- History of liver transplantation for liver failure in the context of chronic HBV infection
- Protected adults, adults unable to express their consent
- Pregnant or breastfeeding women
- Person not affiliated with a Social Security system
- Patient refusal to participate in the project
Where it is running
1 location listed.
- Clinical Research Unit (CRU) Henri Mondor. - Créteil, Créteil, France