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Hepatitis B Infection Surveillance

NCT07727187 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1360

Last updated 2026-07-27

No results posted yet for this study

Summary

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:

1. Describe demographic and virological characteristics of HBsAg-positive patients;
2. Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;
3. Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;
4. Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;
5. Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients;
6. Identify molecular signatures associated with liver disease severity;
7. Compare findings with those of a national cohort conducted 15 years earlier;
8. Collect biological samples for future analyses;
9. 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/Reference Hepatology Centers or to Hepatology or Infectious Diseases Departments.

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.

Conditions

  • Chronic Hepatitis B Infection

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-09-01
Completion
2029-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727187 on ClinicalTrials.gov