Evaluating the HBV Reservoir and Immunological Characteristics in Chronic Hepatitis B Patients
Official title: Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study
Run by Hospices Civils de Lyon · NCT06047093 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | March 8, 2024 |
| Main results expected | March 8, 2030 |
| Study ends | March 8, 2030 |
| Registry record updated | April 21, 2026 |
| Trial ID | NCT06047093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 and older who are chronically infected with HBV, regardless of their treatment status.
✕Probably not a fit
Patients with decompensated cirrhosis, hepatocellular carcinoma, or those co-infected with HCV or HIV 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 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.
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 gone: While the approach of investigating intrahepatic HBV reservoirs is relatively novel, similar studies have shown promise in understanding viral persistence and developing targeted therapies.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Impact of functional cure on patient-reported outcomes in chronic hepatitis B
This study tests whether people with chronic hepatitis B who achieve a functional cure have better patient-reported outcomes compared to those not cured, relapse, or healthy controls.
-
Sequential combination therapy for functional cure of chronic hepatitis B
This trial tests a new two-drug approach to see if adding immunotherapy to ongoing HBV treatment can lead to loss of hepatitis B surface antigen in adults with chronic hepatitis B.
-
Combination therapy for functional cure in chronic hepatitis B
This phase 2 trial tests whether a sequence of anti-PD-1/PD-L1 antibodies with pegylated interferon and nucleos(t)ide analogues can achieve functional cure (HBsAg loss) in adults with chronic hepatitis B.
-
GST-HG131/GST-HG141 tablets vs placebo in chronic hepatitis B
A phase IIa trial tests GST-HG131 and GST-HG141 tablets against placebo to see if they are safe and help people with chronic hepatitis B.
-
AHB-137 injection in people with chronic hepatitis B
This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.
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AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function
This study tests how AHB-137 behaves in the body and its safety in adults with chronic hepatitis B who have mild to moderate liver problems or normal liver function.
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.