New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Clinical Research Unit (CRU) Henri Mondor.
RECRUITING
Créteil
Contact Information
Primary
Vincent LEROY, Dr
vincent.leroy2@aphp.fr
+33 0149812325
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2038-11-27
Participants
Target number of participants: 900
Treatments
Cohort Study on Chronic HBV Infection
This study is a cohort study. It follows a group of patients infected with HBV (Hepatitis B) over an extended period to evaluate the predictive role of biomarkers in the progression of the infection and the response to antiviral treatment. Patients are monitored over time, with regular sample collection to measure biomarkers and assess clinical and biological events, such as seroconversion or the emergence of complications like cirrhosis or liver cancer.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov