Actively Recruiting
New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02
900
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old
- Chronic HBV infection (HBsAg positive for more than 6 months)
- Patient receiving care at Henri Mondor-Albert Chenevier University Hospital
You will not qualify if you...
- History of liver transplantation due to chronic HBV infection
- Adults unable to give consent or protected adults
- Pregnant or breastfeeding women
- Not affiliated with a Social Security system
- Patient refusal to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Clinical Research Unit (CRU) Henri Mondor.
Créteil, Créteil, France, 94000
Actively Recruiting
Research Team
V
Vincent LEROY, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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