Chronic Hepatitis B InfectionHEPB-SURVEYNCT07727187
Hepatitis B Infection Surveillance
An observational study of Chronic Hepatitis B Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B Infection
- How many people
- 1,360 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Stéphane Chevaliez
Créteil, 9400
Stéphane Chevaliez, PhD, +33 1 4981 2828, stephane.chevaliez@aphp.fr
Meriem Harrabi, PhD, +331 4981 4845, meriem.harrabi@aphp.fr
About this study
Official title: National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert/Reference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)
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.
Read more
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:
- Describe demographic and virological characteristics of HBsAg-positive patients;
- Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;
- Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;
- Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;
- Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients;
- Identify molecular signatures associated with liver disease severity;
- Compare findings with those of a national cohort conducted 15 years earlier;
- Collect biological samples for future analyses;
- 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
- Keywords
- Hepatitis B, Chronic HBV infection, Hepatitis D, HBV, HDV, Liver fibrosis, Antiviral treatment
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Hepatitis D, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One including subjects >18-year-old with chronic HBV infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (at inclusion)
Secondary outcomes (10)
Demographic characteristics of newly identified chronic HBsAg carriers
age, sex, country of birth
Measured: 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
Measured: Baseline (at inclusion)
Antiviral treatment eligibility and response
ALT and AST levels, HBV DNA level, HBsAg level, HBe status and severity of liver disease
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (at inclusion)
Biobank collection
Collection and storage of whole blood samples
Measured: Baseline (at inclusion)
Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg)
sensitivity, specificity, positive and negative predictive values
Measured: Baseline (at inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727187
- Sponsor's protocol ID
- APHP 251807
- Acronym
- HEPB-SURVEY
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Surveillance of Patients With Chronic Hepatitis B (±D) From Expert/Reference Hepatology Centers (FPRH), Hepatology Departments in General Hospitals (ANGH), and the Virology and Medical Pharmacology Network (ANRS-MIE)
- ClinicalTrials.gov ID
- NCT07727187
- Acronym / sponsor ID
- HEPB-SURVEY / APHP 251807
- Conditions
- Chronic Hepatitis B Infection
- Keywords
- Hepatitis B, Chronic HBV infection, Hepatitis D, HBV, HDV, Liver fibrosis, Antiviral treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2029 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Describe demographic and virological characteristics of HBsAg-positive patients;
- Determine the proportion of patients eligible for HBV treatment and evaluate treatment response at 6 and 12 months;
- Assess the utility of novel virological markers for classifying patients according to phases of chronic HBV infection;
- Evaluate HBsAg thresholds, in combination with other markers, for distinguishing HBeAg-negative chronic infection from HBeAg-negative chronic hepatitis;
- Compare clinical and virological characteristics of HBV-monoinfected and HBV/HDV-coinfected patients;
- Identify molecular signatures associated with liver disease severity;
- Compare findings with those of a national cohort conducted 15 years earlier;
- Collect biological samples for future analyses;
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One including subjects >18-year-old with chronic HBV infection | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4)
Time frame: Baseline (at inclusion)
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
10 secondary outcomes
Demographic characteristics of newly identified chronic HBsAg carriers
Time frame: Baseline (at inclusion)
Virological characteristics of newly identified chronic HBsAg carriers
Time frame: Baseline (at inclusion)
Antiviral treatment eligibility and response
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
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
Time frame: Baseline (at inclusion)
Characteristics of HDV infection
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
Time frame: Baseline (at inclusion)
Comparison with previous French cohort data (2008-2012)
Time frame: Baseline (at inclusion)
Biobank collection
Time frame: Baseline (at inclusion)
Clinical performance of ultra-sensitive HBcrAg assay (iTACT-HBcrAg)
Time frame: Baseline (at inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Chevaliez, PhD (+33 1 4981 2828, stephane.chevaliez@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with significant fibrosis (METAVIR score ≥F2), including cirrhosis (METAVIR score F4) (time frame: Baseline (at inclusion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.