Hepatitis B Infection Surveillance

NCT07727187 | Not Yet Recruiting

• 1 other identifier: APHP 251807
• Study Type: observational
• Target: 1,360
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Hepatitis B Infection

Keywords

Hepatitis B; Chronic HBV infection; Hepatitis D; HBV; HDV; Liver fibrosis; Antiviral treatment

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline (at inclusion)

Secondary Outcomes (10)

• Demographic characteristics of newly identified chronic HBsAg carriers

  Baseline (at inclusion)

• Virological characteristics of newly identified chronic HBsAg carriers

  Baseline (at inclusion)

• Antiviral treatment eligibility and response

  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

  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

  Baseline (at inclusion)

Study Arms (1)

One including subjects >18-year-old with chronic HBV infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 18 years or older
• Chronic HBsAg carriage
• First referral to participating expert/reference hepatology centers or hepatology/infectious diseases departments
• Written informed consent obtained
• Affiliation with national health insurance system or equivalent coverage

You may not qualify if:

• Telephone-only referrals or medical record-only consultations
• Telemedicine-only consultations
• Inability or unwillingness to comply with study procedures
• Inability to understand study objectives or procedures
• Individuals deprived of liberty, under guardianship or under conservatorship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Stéphane Chevaliez

Créteil, 9400, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples (approximately 5-7 mL collected in EDTA tubes)

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B; Hepatitis D; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; RNA Virus Infections; Fibrosis

Central Study Contacts

Stéphane Chevaliez, PhD

CONTACT

+33 1 4981 2828; stephane.chevaliez@aphp.fr

Meriem Harrabi, PhD

CONTACT

+331 4981 4845; meriem.harrabi@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)