[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648881":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":21,"responsibleParty":37,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":10,"enrollmentInfo":49,"targetDuration":10,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":64,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"One including subjects >18-year-old with chronic HBV infection",null,[12,17],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},"Stéphane Chevaliez, PhD","CONTACT","+33 1 4981 2828","stephane.chevaliez@aphp.fr",{"name":18,"role":14,"phone":19,"phoneExt":10,"email":20},"Meriem Harrabi, PhD","+331 4981 4845","meriem.harrabi@aphp.fr",[22],{"facility":23,"status":10,"city":24,"state":10,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Stéphane Chevaliez","Créteil","9400","France","FR",{"type":29,"coordinates":30},"Point",[31,32],2.46569,48.79266,{"lat":32,"lon":31},[35,36],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},{"name":18,"role":14,"phone":19,"phoneExt":10,"email":20},{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100648881","hepatitis-b-infection-surveillance-100648881",false,"NCT07727187","Hepatitis B Infection Surveillance","National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert\u002FReference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)","HEPB-SURVEY","Inclusion Criteria:\n\n* Age 18 years or older\n* Chronic HBsAg carriage\n* First referral to participating expert\u002Freference hepatology centers or hepatology\u002Finfectious diseases departments\n* Written informed consent obtained\n* Affiliation with national health insurance system or equivalent coverage\n\nExclusion Criteria:\n\n* Telephone-only referrals or medical record-only consultations\n* Telemedicine-only consultations\n* Inability or unwillingness to comply with study procedures\n* Inability to understand study objectives or procedures\n* Individuals deprived of liberty, under guardianship or under conservatorship","ALL","18 Years",{"count":50,"type":51},1360,"ESTIMATED","OBSERVATIONAL","France is a low-endemicity country for hepatitis B virus (HBV) infection. In 2016, the prevalence of chronic HBV infection in the general population was estimated at 0.3%, corresponding to more than 135,000 HBsAg-positive individuals, of whom 82% were unaware of their infection. Data on hepatitis D virus (HDV) infection remain limited; however, available studies suggest a prevalence of 6% to 10% among HBsAg-positive individuals. Despite current guideline recommendations, up to 35% of newly diagnosed HBsAg-positive patients between 2018 and 2022 were not screened for HDV infection.\n\nThe World Health Organization (WHO) targets for 2030 include a 90% reduction in the incidence of chronic viral hepatitis, a 65% reduction in hepatitis-related mortality, and treatment coverage for 80% of eligible diagnosed individuals. Achieving these goals will require strengthening HBV and HDV screening strategies and improving linkage to care and retention throughout the care cascade.\n\nObjectives: The primary objective is to assess the severity of liver disease, including significant fibrosis (≥F2) and cirrhosis (F4), among adults newly diagnosed with chronic HBV infection (with or without HDV infection) at Expert\u002FReference Hepatology Centers and Hepatology or Infectious Diseases Departments.\n\nThe secondary objectives are to:\n\n1. Describe demographic and virological characteristics of HBsAg-positive patients;\n2. Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;\n3. Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;\n4. Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;\n5. Compare clinical and virological characteristics of HBV-monoinfected and HBV\u002FHDV-coinfected patients;\n6. Identify molecular signatures associated with liver disease severity;\n7. Compare findings with those of a national cohort conducted 15 years earlier;\n8. Collect biological samples for future analyses;\n9. Assess the clinical utility of a highly sensitive HBcrAg assay. Method: This is a multicenter, observational study including all adults aged ≥18 years with chronic HBV infection, whether managed as outpatients or inpatients, who are newly referred to Expert\u002FReference Hepatology Centers or to Hepatology or Infectious Diseases Departments.\n\nConclusions: This study will generate updated national data on liver disease severity, treatment eligibility, and virological characteristics among adults newly diagnosed with chronic HBV infection in France.",[55],"Chronic Hepatitis B Infection",[57,58,59,60,61,62,63],"Hepatitis B","Chronic HBV infection","Hepatitis D","HBV","HDV","Liver fibrosis","Antiviral treatment","NOT_YET_RECRUITING","2026-07-21",{"date":67,"type":68},"2026-07-27","ACTUAL",{"date":70,"type":51},"2026-09-01",{"date":72,"type":51},"2029-09-01",{"name":5,"class":6},1]