Follow-up of HBsAg Inactive Carriers Study
PIBAC
1 other identifier
interventional
619
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2014
Longer than P75 for not_applicable
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2014
CompletedStudy Start
First participant enrolled
September 16, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2022
CompletedApril 6, 2022
April 1, 2022
1.5 years
September 15, 2014
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 ".
every year, during 5 years for each
Study Arms (1)
Inactive carriers
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Ch General Du Pays D'Aix
Aix-en-Provence, 13616, France
CH d'AVIGNON
Avignon, 84902, France
Clinique de La Chataigneraie
Beaumont, 63110, France
Medical Center Besancon
Besançon, 25000, France
Clinical Center Bourgoin Jallieu
Bourgoin, 38300, France
Hopital Sainte Camille
Bry-sur-Marne, 94360, France
Ch de Caen
Caen, 14033, France
Ch Sud Fracilien Jean Jaures
Corbeil-Essonnes, 91100, France
CH CREIL
Creil, 60109, France
Ch de Creteil
Créteil, 94000, France
CH de GONESSE
Gonesse, 95503, France
Clinique Du Palais
Grasse, 06130, France
Ch D'Hyeres
Hyères, 83407, France
Ch de Lagny Marne La Valee
Jossigny, 77600, France
Chd Vendee
La Roche-sur-Yon, 85925, France
Ch Du Mans
Le Mans, 72037, France
Medical Center La Sauvegarde
Lyon, 69009, France
Ch de Meaux
Meaux, 77104, France
CH MELUN
Melun, 77011, France
Ch Montelimar
Montélimar, 26126, France
Ch de Montfermeil
Montfermeil, 93370, France
Clinical Center Montpellier
Montpellier, 34070, France
Medical Center Nanterre
Nanterre, 92000, France
CHR d'ORLEANS
Orléans, 45067, France
Medical Center Paris 7
Paris, 75007, France
Ch de Pau
Pau, 64000, France
Hopital Saint Jean
Perpignan, 66046, France
Ch de La Region Annnecienne
Pringy, 74374, France
Ch Saint Brieuc
Saint-Brieuc, 22027, France
Ch de Saint Denis
Saint-Denis, 93200, France
Ch de Vannes
Vannes, 56017, France
Chi Villeneauve Saint Georges
Villeneuve-Saint-Georges, 94190, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier CAUSSE
CHR Orleans
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2014
First Posted
September 25, 2014
Study Start
September 16, 2014
Primary Completion
March 31, 2016
Study Completion
February 4, 2022
Last Updated
April 6, 2022
Record last verified: 2022-04