Clinical trial · Observational
New HBV Infection Biomarkers: Clinical Characterization and Impact on Management
New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Hepatitis B Virus (HBV) Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of blood samples for the study of HBV biomarkers | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cohort Study on Chronic HBV Infection
- description
- 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.
- interventionNames
- Biological: Collection of blood samples for the study of HBV biomarkers
Primary outcomes (1)
- measure
- HBsAg Seroconversion Rate
- timeFrame
- 3 months
- description
- Defined by the absence of detectable AgHBs in the serum using ELISA test
Secondary outcomes (5)
- measure
- Incidence of Biological Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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