Evaluating new biomarkers for chronic Hepatitis B infection management
New Biomarkers of HBV Infection: Clinico-Biological Characterization and Impact on Infection Management
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 |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Créteil, Créteil) |
| Trial ID | NCT06906016 on ClinicalTrials.gov |
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).
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise in evaluating similar biomarkers for HBV, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Créteil, Créteil
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.