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Follow-up of HBsAg Inactive Carriers Study (PIBAC)

Primary Purpose

Hepatitis B

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
inactive carrier
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ch General Du Pays D'Aix
  • CH d'AVIGNON
  • Clinique de La Chataigneraie
  • Medical Center Besancon
  • Clinical Center Bourgoin Jallieu
  • Hopital Sainte Camille
  • Ch de Caen
  • Ch Sud Fracilien Jean Jaures
  • CH CREIL
  • Ch de Creteil
  • CH de GONESSE
  • Clinique Du Palais
  • Ch D'Hyeres
  • Ch de Lagny Marne La Valee
  • Chd Vendee
  • Ch Du Mans
  • Medical Center La Sauvegarde
  • Ch de Meaux
  • CH MELUN
  • Ch Montelimar
  • Ch de Montfermeil
  • Clinical Center Montpellier
  • Medical Center Nanterre
  • CHR d'ORLEANS
  • Medical Center Paris 7
  • Ch de Pau
  • Hopital Saint Jean
  • Ch de La Region Annnecienne
  • Ch Saint Brieuc
  • Ch de Saint Denis
  • Ch de Vannes
  • Chi Villeneauve Saint Georges

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Inactive carriers

Arm Description

Outcomes

Primary Outcome Measures

Incidence of unfavourable liver events
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 ".

Secondary Outcome Measures

Full Information

First Posted
September 15, 2014
Last Updated
April 5, 2022
Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF, Faculté de mathématiques ORLEANS
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1. Study Identification

Unique Protocol Identification Number
NCT02247752
Brief Title
Follow-up of HBsAg Inactive Carriers Study
Acronym
PIBAC
Official Title
Follow-up of HBsAg Inactive Carriers Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
March 31, 2016 (Actual)
Study Completion Date
February 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF, Faculté de mathématiques ORLEANS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
619 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inactive carriers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
inactive carrier
Intervention Description
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 Measure Information:
Title
Incidence of unfavourable liver events
Description
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 ".
Time Frame
every year, during 5 years for each

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier CAUSSE
Organizational Affiliation
CHR Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch General Du Pays D'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
CH d'AVIGNON
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Clinique de La Chataigneraie
City
Beaumont
ZIP/Postal Code
63110
Country
France
Facility Name
Medical Center Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Clinical Center Bourgoin Jallieu
City
Bourgoin Jallieu
ZIP/Postal Code
38300
Country
France
Facility Name
Hopital Sainte Camille
City
Bry sur Marne
ZIP/Postal Code
94360
Country
France
Facility Name
Ch de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Ch Sud Fracilien Jean Jaures
City
Corbeil essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
CH CREIL
City
Creil
ZIP/Postal Code
60109
Country
France
Facility Name
Ch de Creteil
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CH de GONESSE
City
Gonesse
ZIP/Postal Code
95503
Country
France
Facility Name
Clinique Du Palais
City
Grasse
ZIP/Postal Code
06130
Country
France
Facility Name
Ch D'Hyeres
City
Hyeres
ZIP/Postal Code
83407
Country
France
Facility Name
Ch de Lagny Marne La Valee
City
Jossigny
ZIP/Postal Code
77600
Country
France
Facility Name
Chd Vendee
City
La Roche sur yon
ZIP/Postal Code
85925
Country
France
Facility Name
Ch Du Mans
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Medical Center La Sauvegarde
City
Lyon
ZIP/Postal Code
69009
Country
France
Facility Name
Ch de Meaux
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
CH MELUN
City
Melun
ZIP/Postal Code
77011
Country
France
Facility Name
Ch Montelimar
City
Montelimar
ZIP/Postal Code
26126
Country
France
Facility Name
Ch de Montfermeil
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Clinical Center Montpellier
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Medical Center Nanterre
City
Nanterre
ZIP/Postal Code
92000
Country
France
Facility Name
CHR d'ORLEANS
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Medical Center Paris 7
City
Paris
ZIP/Postal Code
75007
Country
France
Facility Name
Ch de Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Hopital Saint Jean
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Ch de La Region Annnecienne
City
Pringy
ZIP/Postal Code
74374
Country
France
Facility Name
Ch Saint Brieuc
City
Saint Brieuc
ZIP/Postal Code
22027
Country
France
Facility Name
Ch de Saint Denis
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Ch de Vannes
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
Chi Villeneauve Saint Georges
City
Villeneuve Saint Georges
ZIP/Postal Code
94190
Country
France

12. IPD Sharing Statement

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Follow-up of HBsAg Inactive Carriers Study

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