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Follow-up of HBsAg Inactive Carriers Study (PIBAC)

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ClinicalTrials.gov Identifier: NCT02247752
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
Faculté de mathématiques ORLEANS
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Other: inactive carrier Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Follow-up of HBsAg Inactive Carriers Study
Study Start Date : September 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 ".



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247752


Contacts
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Contact: Antoine LEBRERE 33 2 38 74 42 01 antoine.lebrere@chr-orleans.fr

Locations
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France
Ch General Du Pays D'Aix Recruiting
Aix en Provence, France, 13616
Sub-Investigator: Séverine HOMMEL         
CH d'AVIGNON Recruiting
Avignon, France, 84902
Sub-Investigator: Jean Pierre ARPURT         
Clinique de La Chataigneraie Recruiting
Beaumont, France, 63110
Sub-Investigator: Corinne BONNY         
Medical Center Besancon Recruiting
Besancon, France, 25000
Sub-Investigator: Solange BRESSON-HADNI         
Clinical Center Bourgoin Jallieu Recruiting
Bourgoin Jallieu, France, 38300
Sub-Investigator: Thierry FONTANGES         
Hopital Sainte Camille Recruiting
Bry sur Marne, France, 94360
Sub-Investigator: David ZANDITENAS         
Ch de Caen Recruiting
Caen, France, 14033
Sub-Investigator: Isabelle OLLIVIER-HOURMAND         
Ch Sud Fracilien Jean Jaures Active, not recruiting
Corbeil essonnes, France, 91100
CH CREIL Recruiting
Creil, France, 60109
Sub-Investigator: Jean-François CADRANEL         
Ch de Creteil Recruiting
Creteil, France, 94000
Sub-Investigator: Isabelle ROSA         
CH de GONESSE Active, not recruiting
Gonesse, France, 95503
Clinique Du Palais Active, not recruiting
Grasse, France, 06130
Ch D'Hyeres Recruiting
Hyeres, France, 83407
Sub-Investigator: Christophe RENOU         
Ch de Lagny Marne La Valee Recruiting
Jossigny, France, 77600
Sub-Investigator: Gilles MACAIGNE         
Chd Vendee Recruiting
La Roche sur yon, France, 85925
Sub-Investigator: Mathieu SCHNEE         
Ch Du Mans Active, not recruiting
Le Mans, France, 72037
Medical Center La Sauvegarde Recruiting
Lyon, France, 69009
Sub-Investigator: Sylvain BEORCHIA         
Ch de Meaux Recruiting
Meaux, France, 77104
Sub-Investigator: Hatem SALLOUM         
CH MELUN Recruiting
Melun, France, 77011
Sub-Investigator: Simona COSCONEA CIOACA         
Ch Montelimar Active, not recruiting
Montelimar, France, 26126
Ch de Montfermeil Active, not recruiting
Montfermeil, France, 93370
Clinical Center Montpellier Recruiting
Montpellier, France, 34070
Sub-Investigator: Bertrand HANSLIK         
Medical Center Nanterre Recruiting
Nanterre, France, 92000
Sub-Investigator: Nathalie BOYER         
CHR d'ORLEANS Recruiting
Orleans, France, 45067
Principal Investigator: Xavier CAUSSE         
Medical Center Paris 7 Recruiting
Paris, France, 75007
Sub-Investigator: Corrine CASTELNAU         
Ch de Pau Active, not recruiting
Pau, France, 64000
Hopital Saint Jean Active, not recruiting
Perpignan, France, 66046
Ch de La Region Annnecienne Recruiting
Pringy, France, 74374
Sub-Investigator: Frédéric HELUWAERT         
Ch Saint Brieuc Active, not recruiting
Saint Brieuc, France, 22027
Ch de Saint Denis Recruiting
Saint Denis, France, 93200
Sub-Investigator: Hélène LABADIE         
Ch de Vannes Active, not recruiting
Vannes, France, 56017
Chi Villeneauve Saint Georges Recruiting
Villeneuve Saint Georges, France, 94190
Sub-Investigator: Louis BETTAN         
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
Faculté de mathématiques ORLEANS
Investigators
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Principal Investigator: Xavier CAUSSE CHR Orleans

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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT02247752     History of Changes
Other Study ID Numbers: CHRO -2014-02
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Keywords provided by Centre Hospitalier Régional d'Orléans:
hepatitis
HBV
chronic hepatitis
HCC
cirrhosis
quantitative HBsAg
HBsAg inactive carriers
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections