Evaluating new biomarkers for chronic Hepatitis B infection management
Official title: New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
Run by Assistance Publique - Hôpitaux de Paris · NCT06906016 · Data updated 2026-11-12
This study is testing new blood markers to see if they can help doctors better manage chronic Hepatitis B and predict serious health issues for patients receiving care at a hospital.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 900 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Créteil) |
| Status | Recruiting |
| Started | November 28, 2023 |
| Main results expected | November 27, 2038 |
| Study ends | November 27, 2038 |
| Registry record updated | April 2, 2025 |
| Trial ID | NCT06906016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with chronic HBV infection who have been positive for HBsAg for more than six months.
✕Probably not a fit
Patients with a history of liver transplantation, those unable to provide consent, pregnant or breastfeeding women, and individuals not affiliated with a Social Security scheme may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on chronic Hepatitis B virus (HBV) infection, which affects millions globally and can lead to severe liver diseases. It aims to evaluate the predictive role of new biomarkers, specifically HBV core-related antigen (HBcrAg) and HBV RNA, in managing the disease and predicting clinical outcomes. The study will involve patients diagnosed with chronic HBV infection who are receiving care at Henri Mondor-Albert Chenevier University Hospital. Blood samples will be collected to assess the association of these biomarkers with HBsAg seroconversion and clinical events like cirrhosis and hepatocellular carcinoma (HCC).
Why it matters
Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with chronic HBV infection.
How similar studies have gone: Other studies have shown promise in evaluating similar biomarkers for HBV, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Clinical Research Unit (CRU) Henri Mondor.
Créteil, Créteil, France Recruiting
Study contacts
- Study coordinator: Vincent LEROY, Dr
- Email: vincent.leroy2@aphp.fr
- Phone: +33 0149812325
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.