Studies liver cells from a fine needle sample in chronic hepatitis B
Studies liver cells and immune response in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients
Key facts
- Where
- Lyon, FranceSee the site
Where in France
- Hepatology Department - Hospices Civils de LyonLyon, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospices Civils de Lyon
- Trial code
- NCT06047093
- Record updated
- 21 April 2026
- Original description
Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation).Read full original descriptionShow less
Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study
Two hundred and ninety-six million people worldwide are chronically infected with the hepatitis B virus (HBV), with around 750,000 deaths each year linked to the development of cirrhosis or hepatocellular carcinoma. Current treatments based on nucleoside analogues (NA) achieve virological cure in only 5% of cases at 10 years. The virological persistence of HBV is explained by the persistence of cccDNA (covalently-closed circular DNA) in the nucleus of hepatocytes. Complex and poorly understood interactions between immunological and virological responses explain the persistence of ccccDNA. A better understanding of the immunological and virological interactions of the intrahepatic compartment during chronic HBV infection is needed to better understand the mechanisms of viral persistence and for research and development of new drugs to achieve the goal of a functional cure for HBV (defined as the prolonged loss of Hepatitis B surface antigen (HBsAg) after cessation of treatment, associated with a decrease in intrahepatic cccDNA or its transcriptional inactivation).
The intra-hepatic compartment can be explored by liver biopsy. A fine needle aspiration (FNA) technique is used to characterize primary hepatic tumors, with fewer complications than liver biopsy. One study has validated its use for immunological exploration of the intra-hepatic compartment. Finally, a recently published study confirms a correlation between FNA and liver biopsy virological markers in patients with chronic HBV infection. However, no combined immuno-virological study has been carried out to explore this intra-hepatic compartment by FNA in patients with chronic HBV infection.
The investigators will assess the intrahepatic compartment of patients chronically infected with HBV (+/- hepatitis Delta (HDV)) to understand the mechanisms of viral persistence and characterize host immune responses to HBV. These investigations will make it possible to determine the immuno-virological profiles of patients who would benefit from intensification of antiviral treatment or, potentially, discontinuation of antiviral therapy.
Inclusion: 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: Liver transplant patients (even if liver transplantation for HBV),; Persons under psychiatric care,; Patients with abdominal skin lesions and/or infections; Contraindication to lidocaine administration (allergy or hypersensitivity to the product); Patients co-infected with HCV (positive serum viral load) and/or HIV (regardless of serum viral load); Pregnant, parturient or breast-feeding women,; Patients with decompensated cirrhosis; Patients with hepatocellular carcinoma (suspected or proven),; Patients participating at the time of inclusion in an interventional study; 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.