Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT06047093
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2023-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Five groups according to HBsAg quantification (3 distinct groups with or without nucleoside analogues), HDV co-infection and HBsAg loss.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-03-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2023-09-14', 'studyFirstSubmitQcDate': '2023-09-14', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interaction between immune response against HBV and intrahepatic HBV viral load', 'timeFrame': 'Baseline', 'description': 'The main objective is to analyze the interaction between intrahepatic adaptive immune responses (Number and functional profile of CD4+ T lymphocytes and CD8+ B lymphocytes) and intrahepatic HBV viral load obtained from FNA.\n\nImmune and virological responses obtained from the FNA performed.'}], 'secondaryOutcomes': [{'measure': 'Correlation between intrahepatic HBV markers and HBV serum markers', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months and 24 months after inclusion', 'description': 'Correlate intrahepatic markers of HBV (copies of intra-hepatic HBV, cccDNA, cccDNA transcriptional activity, HBV RNA) and new serum markers of HBV cure (circulating viral RNA, HBcrAg) and their evolution over time Intrahepatic HBV markers obtained from the FNA performed. New serum markers are taken at each visit for 24 months'}, {'measure': 'Intrahepatic immune and virological responses in relation to the phases of HBV or HDV co-infection', 'timeFrame': 'Baseline', 'description': 'Analyze immune (copies of intra-hepatic HBV, cccDNA and cccDNA transcriptional activity) and virological responses (Number and functional profile of CD4+ T lymphocytes and CD8+ B lymphocytes) as a function of the phases of chronic HBV infection and co-infection with HDV.\n\nImmune and virological responses obtained from the FNA performed.'}, {'measure': 'Intrahepatic immunological and virological responses according to the presence or absence of NA', 'timeFrame': 'Baseline', 'description': 'Analyze immune (copies of intra-hepatic HBV, cccDNA and cccDNA transcriptional activity) and virological responses (Number and functional profile of CD4+ T lymphocytes and CD8+ B lymphocytes) according to the presence or absence of NA treatment.\n\nImmune and virological responses obtained from the FNA performed.'}, {'measure': 'Assessing patient tolerance and acceptability of FNA', 'timeFrame': 'Baseline (before then after FNA)', 'description': 'A questionnaire on the acceptability and tolerance of FNA will be given to each patient at the inclusion visit and after FNA has been performed (15-30 days after inclusion).\n\nAn FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after FNA had been performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B', 'HBV', 'cccDNA', 'functional cure', 'FNA', 'HBsAg'], 'conditions': ['Chronic Hepatitis b']}, 'descriptionModule': {'briefSummary': '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).\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Patients chronically infected with hepatitis B virus at any stage of infection\n* Nucleoside Analogues-treated or untreated\n* Co-infected or not with HDV\n* Included in the prospective CirB-RNA study (part of the CirB-RNA university research program) (ID-RCB : 2018-A02558-47, NCT03825458)\n* Patient informed of the study and having signed a consent form\n\nExclusion Criteria:\n\n* Pregnant, parturient or breast-feeding women,\n* Patients with decompensated cirrhosis\n* Patients with hepatocellular carcinoma (suspected or proven),\n* Liver transplant patients (even if liver transplantation for HBV),\n* Patients co-infected with HCV (positive serum viral load) and/or HIV (regardless of serum viral load).\n* Patients participating at the time of inclusion in an interventional study\n* Persons under psychiatric care,\n* Persons admitted to a health or social institution for purposes other than research\n* Adults under legal protection (legal guardianship, tutorship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme.\n* Patients with abdominal skin lesions and/or infections.\n* Contraindication to lidocaine administration (allergy or hypersensitivity to the product).'}, 'identificationModule': {'nctId': 'NCT06047093', 'acronym': 'RES-HBV', 'briefTitle': 'Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Evaluation of the Intrahepatic Hepatitis B Virus Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients - Pilot Study', 'orgStudyIdInfo': {'id': '69HCL23_0275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HBsAg <100 IU/ml', 'description': 'Patients chronically mono-infected with HBV, whose HBsAg is less than 100 IU/ml (patients treated or not with NA)', 'interventionNames': ['Procedure: Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'Biological: Creation of a serum biobank', 'Other: FNA feasibility and acceptability questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'HBsAg between 100 and 3000 IU/ml', 'description': 'Patients chronically mono-infected with HBV, with HBsAg levels \\>100 and \\<3000 IU/ml (patients treated or not with NA).', 'interventionNames': ['Procedure: Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'Biological: Creation of a serum biobank', 'Other: FNA feasibility and acceptability questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'HBsAg ≥ 3000 IU/ml', 'description': 'Patients chronically mono-infected with HBV, with HBsAg levels ≥ 3000 IU/ml (patients treated or not with NA).', 'interventionNames': ['Procedure: Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'Biological: Creation of a serum biobank', 'Other: FNA feasibility and acceptability questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'Loss of HBsAg (spontaneously or under NA)', 'description': 'Patients with loss of HBsAg (spontaneously or under NA). This group will allow comparison of the HBsAg loss immuno-virological profile with that of patients with active infection and varying levels of HBsAg (groups 1-3 and 5) and aid in identifying of predictors of functional cure. The identification of determinants of HBV functional cure is fundamental and is comparable to investigations that have been carried out in HIV-infected "elite controllers".', 'interventionNames': ['Procedure: Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'Biological: Creation of a serum biobank', 'Other: FNA feasibility and acceptability questionnaire']}, {'type': 'EXPERIMENTAL', 'label': 'Patients co-infected with HBV and HDV', 'description': 'Patients co-infected with HDV (positive HDV viral load), regardless of HBsAg level (presence or absence of HBV or HDV treatment)', 'interventionNames': ['Procedure: Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'Biological: Creation of a serum biobank', 'Other: FNA feasibility and acceptability questionnaire']}], 'interventions': [{'name': 'Investigation of the intrahepatic compartment using the fine needle aspiration (FNA) technique', 'type': 'PROCEDURE', 'description': 'The FNA will be performed at the Croix Rousse digestive pathology day hospital of the Hospices Civils de Lyon by a doctor from the hepatology department who has been trained to perform FNA.\n\nAfter echography, a subcutaneous anesthesia with LIDOCAÏNE is administered. Two FNA passages will be performed for virological and immunological analyses. The patient will be monitored in the supine position for 1 hour after the procedure.\n\nA single FNA will be performed during the study.', 'armGroupLabels': ['HBsAg <100 IU/ml', 'HBsAg between 100 and 3000 IU/ml', 'HBsAg ≥ 3000 IU/ml', 'Loss of HBsAg (spontaneously or under NA)', 'Patients co-infected with HBV and HDV']}, {'name': 'Creation of a serum biobank', 'type': 'BIOLOGICAL', 'description': '42ml blood sample for study of circulating peripheral blood mononuclear cells (PBMC) and new circulating hepatitis B markers. These samples will enable us to gain a better understanding of peripheral immune responses and to correlate intrahepatic virological data with new serum markers of HBV.', 'armGroupLabels': ['HBsAg <100 IU/ml', 'HBsAg between 100 and 3000 IU/ml', 'HBsAg ≥ 3000 IU/ml', 'Loss of HBsAg (spontaneously or under NA)', 'Patients co-infected with HBV and HDV']}, {'name': 'FNA feasibility and acceptability questionnaire', 'type': 'OTHER', 'description': 'An FNA feasibility and acceptability questionnaire carried out at inclusion (V1) and after the FNA has been performed.', 'armGroupLabels': ['HBsAg <100 IU/ml', 'HBsAg between 100 and 3000 IU/ml', 'HBsAg ≥ 3000 IU/ml', 'Loss of HBsAg (spontaneously or under NA)', 'Patients co-infected with HBV and HDV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien ZOULIM, PU-PH', 'role': 'CONTACT', 'email': 'fabien.zoulim@chu-lyon.fr', 'phone': '04 26 10 93 55', 'phoneExt': '+33'}, {'name': 'Fabien ZOULIM, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hepatology Department - Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Fabien ZOULIM, PU-PH', 'role': 'CONTACT', 'email': 'fabien.zoulim@chu-lyon.fr', 'phone': '0426109355', 'phoneExt': '+33'}, {'name': 'Bénédicte POUMAROUX', 'role': 'CONTACT', 'email': 'benedicte.poumaroux@chu-lyon.fr', 'phone': '04 26 73 27 37', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Fabien ZOULIM, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Hépatologie de l'Hopital Croix-Rousse"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}