Evaluating the HBV Reservoir and Immunological Characteristics in Chronic Hepatitis B Patients
Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study
This study is trying to understand how the hepatitis B virus hides in the liver and affects the immune system in people with chronic hepatitis B to help find better treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06047093 on ClinicalTrials.gov |
What this trial studies
This study investigates the intrahepatic compartment of patients chronically infected with the hepatitis B virus (HBV) using fine needle aspiration (FNA) techniques. It aims to understand the immunological and virological interactions that contribute to the persistence of HBV, particularly focusing on covalently-closed circular DNA (cccDNA) in hepatocytes. By creating a serum biobank and assessing the feasibility and acceptability of the FNA procedure, the study seeks to gather critical data that could inform the development of new treatments aimed at achieving a functional cure for HBV.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18 and older who are chronically infected with HBV, regardless of their treatment status.
Not a fit: Patients with decompensated cirrhosis, hepatocellular carcinoma, or those co-infected with HCV or HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that may result in a functional cure for chronic hepatitis B.
How similar studies have performed: While the approach of investigating intrahepatic HBV reservoirs is relatively novel, similar studies have shown promise in understanding viral persistence and developing targeted therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥ 18 years of age) * Patients chronically infected with hepatitis B virus at any stage of infection * Nucleoside Analogues-treated or untreated * Co-infected or not with HDV * Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458) * Patient informed of the study and having signed a consent form Exclusion Criteria: * Pregnant, parturient or breast-feeding women, * Patients with decompensated cirrhosis * Patients with hepatocellular carcinoma (suspected or proven), * Liver transplant patients (even if liver transplantation for HBV), * Patients co-infected with HCV (positive serum viral load) and/or HIV (regardless of serum viral load). * Patients participating at the time of inclusion in an interventional study * Persons under psychiatric care, * Persons admitted to a health or social institution for purposes other than research * Adults under legal protection (legal guardianship, tutorship, curatorship) * Persons not affiliated to a social security scheme or beneficiaries of a similar scheme. * Patients with abdominal skin lesions and/or infections. * Contraindication to lidocaine administration (allergy or hypersensitivity to the product).
Where this trial is running
Lyon
- Hepatology Department - Hospices Civils de Lyon — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Fabien ZOULIM, PU-PH — Service d'Hépatologie de l'Hopital Croix-Rousse
- Study coordinator: Fabien ZOULIM, PU-PH
- Email: fabien.zoulim@chu-lyon.fr
- Phone: 0426109355
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.