NCT06047093 Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients
| NCT ID | NCT06047093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Chronic Hepatitis b |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-08 |
| Primary Completion | 2030-03-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-03-08 with a primary completion date of 2030-03-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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).
Contact & Investigator
Fabien ZOULIM, PU-PH
PRINCIPAL INVESTIGATOR
Service d'Hépatologie de l'Hopital Croix-Rousse
Frequently Asked Questions
Who can join the NCT06047093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Hepatitis b. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047093 currently recruiting?
Yes, NCT06047093 is actively recruiting participants. Contact the research team at fabien.zoulim@chu-lyon.fr for enrollment information.
Where is the NCT06047093 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT06047093 clinical trial?
NCT06047093 is sponsored by Hospices Civils de Lyon. The principal investigator is Fabien ZOULIM, PU-PH at Service d'Hépatologie de l'Hopital Croix-Rousse. The trial plans to enroll 100 participants.