RecruitingNCT06906016

New HBV Infection Biomarkers: Clinical Characterization and Impact on Management

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

900 participants

Start Date

Nov 28, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting and analyzing blood samples from people with chronic hepatitis B infection to identify new biological markers that could better predict disease progression and guide treatment decisions. **You may be eligible if...** - You are 18 or older - You have chronic hepatitis B infection (tested positive for HBsAg for more than 6 months) - You are receiving care at Henri Mondor-Albert Chenevier University Hospital in France **You may NOT be eligible if...** - You have had a liver transplant due to liver failure related to hepatitis B - You are pregnant or breastfeeding - You are not affiliated with the French social security system - You decline to participate - You are a legally protected adult unable to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCollection 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.


Locations(1)

Clinical Research Unit (CRU) Henri Mondor.

Créteil, Créteil, France

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NCT06906016


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