An observational study in Chronic Hepatitis B Infection, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · 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.
The 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.
Objectives: 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/Reference Hepatology Centers and Hepatology or Infectious Diseases Departments.
The secondary objectives are to:
Conclusions: 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.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 1,360 is above the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with chronic hepatitis B surface antigen (HBsAg) carriage, defined as persistent HBsAg positivity for at least 6 months or HBsAg positivity in the absence of anti-HBc IgM antibodies.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4)
Liver disease severity assessed by non-invasive methods (liver stiffness measurement, direct or indirect serum biomarkers, composite scores such as FIB-4) and/or liver biopsy. Significant fibrosis is defined as METAVIR score F2 or higher
Time frame: Baseline (at inclusion)
Demographic characteristics of newly identified chronic HBsAg carriers
age, sex, country of birth
Time frame: Baseline (at inclusion)
Virological characteristics of newly identified chronic HBsAg carriers
HBe status, HBV DNA level, genotype, HBsAg level, HBcrAg level, HBV RNA level, HIV or HCV coinfections
Time frame: Baseline (at inclusion)
Antiviral treatment eligibility and response
ALT and AST levels, HBV DNA level, HBsAg level, HBe status and severity of liver disease
Time frame: Baseline (at inclusion), 6 months and 12 months
Performance of novel virological markers (HBcrAg level and HBV RNA level) in identifying patients at risk of disease progression
ALT and AST levels, HBV DNA level, HBsAg level, HBe status, severity of liver disease (METAVIR score), HBcrAg level and HBV RNA level
Time frame: Baseline (at inclusion)
Diagnostic performance of HBsAg thresholds, in combination with other virological markers for distinguishing HBeAg-negative chronic HBV infection from HBeAg-negative chronic hepatitis B
HBsAg levels, HBe status and HBV DNA levels
Time frame: Baseline (at inclusion)
Characteristics of HDV infection
ALT and AST levels, HBV DNA level, HBsAg and HBcrAg levels, HBe status, HBV genotype, severity of liver disease and proportion of patients treated with bulevirtide with or without pegylated interferon
Time frame: Baseline (at inclusion)
Genome sequence analysis and identification of HBV motifs associated with the severity of liver disease in HBV/HDV-coinfected patients
Whole genome sequence analysis using next-generation sequencing technology
Time frame: Baseline (at inclusion)
Comparison with previous French cohort data (2008-2012)
Evolution of clinical, biological and demographical characteristics of participants enrolled between 2008 and 2012
Time frame: Baseline (at inclusion)
Biobank collection
Collection and storage of whole blood samples
Time frame: Baseline (at inclusion)
Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg)
sensitivity, specificity, positive and negative predictive values
Time frame: Baseline (at inclusion)
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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