Follow-up of HBsAg Inactive Carriers Study (PIBAC)

April 5, 2022 updated by: Centre Hospitalier Régional d'Orléans
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
619

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix en Provence, France, 13616
        • Ch General Du Pays D'Aix
      • Avignon, France, 84902
        • CH d'Avignon
      • Beaumont, France, 63110
        • Clinique de la Chataigneraie
      • Besancon, France, 25000
        • Medical Center Besancon
      • Bourgoin Jallieu, France, 38300
        • Clinical Center Bourgoin Jallieu
      • Bry sur Marne, France, 94360
        • Hopital Sainte Camille
      • Caen, France, 14033
        • Ch de Caen
      • Corbeil essonnes, France, 91100
        • Ch Sud Fracilien Jean Jaures
      • Creil, France, 60109
        • CH Creil
      • Creteil, France, 94000
        • CH de Créteil
      • Gonesse, France, 95503
        • CH de Gonesse
      • Grasse, France, 06130
        • Clinique du Palais
      • Hyeres, France, 83407
        • CH d'HYERES
      • Jossigny, France, 77600
        • Ch de Lagny Marne La Valee
      • La Roche sur yon, France, 85925
        • CHD Vendee
      • Le Mans, France, 72037
        • CH du Mans
      • Lyon, France, 69009
        • Medical Center La Sauvegarde
      • Meaux, France, 77104
        • CH de Meaux
      • Melun, France, 77011
        • CH Melun
      • Montelimar, France, 26126
        • CH Montélimar
      • Montfermeil, France, 93370
        • Ch de Montfermeil
      • Montpellier, France, 34070
        • Clinical Center Montpellier
      • Nanterre, France, 92000
        • Medical Center Nanterre
      • Orleans, France, 45067
        • CHR d'Orléans
      • Paris, France, 75007
        • Medical Center Paris 7
      • Pau, France, 64000
        • CH de Pau
      • Perpignan, France, 66046
        • Hopital Saint Jean
      • Pringy, France, 74374
        • Ch de La Region Annnecienne
      • Saint Brieuc, France, 22027
        • CH Saint Brieuc
      • Saint Denis, France, 93200
        • CH de Saint Denis
      • Vannes, France, 56017
        • CH DE VANNES
      • Villeneuve Saint Georges, France, 94190
        • Chi Villeneauve Saint Georges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HBsAg + since one year or more.

    • HBeAg -, anti-HBe antibodies +
    • HBV-DNA < 20000 UI/ml on all dosages realized during past year (ultra-sensitive PCR with a detection threshold < 20 UI/ml), at least 2 dosages during past year.
    • AST and ALT transaminases < ULN on all dosages realized during past year (at least 3).
    • Age > 18 and < 70
    • We will include consecutively all encountered patients (consultation, hospitalization) and diagnosed as HBsAg inactive carriers in each participating center.

Exclusion Criteria:

  • anti-VHC antibodies +
  • anti-VHD antibodies +
  • anti-VIH antibodies +
  • genetic hemochromatosis
  • liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan, Fibrotest, Hepascore …)
  • Past or present treatment against HBV
  • Ultrasonic diagnosis of HCC or Portal Hypertension
  • non compliant patient whom 5 years follow-up seems uncertain.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Inactive carriers
Other: inactive carrier

Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.

Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of unfavourable liver events
Time Frame: every year, during 5 years for each
The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be " HBsAg inactive carriers ".
every year, during 5 years for each

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Régional d'Orléans

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
Faculté de mathématiques ORLEANS

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xavier CAUSSE, CHR Orléans

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHRO -2014-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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