NCT06906016Recruiting
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 · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 900 (estimated)
- First submitted
- 4 Mar 2025
- Start date
- 28 Nov 2023
- Primary completion date
- 27 Nov 2038
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT06906016
What you commit to
- Study type: Observational
- Planned participants: 900
- From 28 Nov 2023 to the primary completion date, 27 Nov 2038
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of liver transplantation for liver failure in the context of chronic HBV infection
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Unit (CRU) Henri Mondor. Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.