Clinical trial NCT02247752: Follow-up of HBsAg Inactive Carriers Study
Official title: Follow-up of HBsAg Inactive Carriers Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Keywords: hepatitis
HBV
chronic hepatitis
HCC
cirrhosis
quantitative HBsAg
HBsAg inactive carriers
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
Collaborators: name: INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
name: Faculté de mathématiques ORLEANS
First posted: 2014-09-25
Enrollment: 619
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of unfavourable liver events
timeFrame: every year, during 5 years for each
Secondary outcomes:
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Ch General Du Pays D'Aix
city: Avignon
country: France
facility: CH d'AVIGNON
city: Beaumont
country: France
facility: Clinique de La Chataigneraie
city: Besancon
country: France
facility: Medical Center Besancon
city: Bourgoin Jallieu
country: France
facility: Clinical Center Bourgoin Jallieu
city: Bry sur Marne
country: France
facility: Hopital Sainte Camille
city: Caen
country: France
facility: Ch de Caen
city: Corbeil essonnes
country: France
facility: Ch Sud Fracilien Jean Jaures
city: Creil
country: France
facility: CH CREIL
city: Creteil
country: France
facility: Ch de Creteil
city: Gonesse
country: France
facility: CH de GONESSE
city: Grasse
country: France
facility: Clinique Du Palais
city: Hyeres
country: France
facility: Ch D'Hyeres
city: Jossigny
country: France
facility: Ch de Lagny Marne La Valee
city: La Roche sur yon
country: France
facility: Chd Vendee
city: Le Mans
country: France
facility: Ch Du Mans
city: Lyon
country: France
facility: Medical Center La Sauvegarde
city: Meaux
country: France
facility: Ch de Meaux
city: Melun
country: France
facility: CH MELUN
city: Montelimar
country: France
facility: Ch Montelimar
city: Montfermeil
country: France
facility: Ch de Montfermeil
city: Montpellier
country: France
facility: Clinical Center Montpellier
city: Nanterre
country: France
facility: Medical Center Nanterre
city: Orleans
country: France
facility: CHR d'ORLEANS
city: Paris
country: France
facility: Medical Center Paris 7
city: Pau
country: France
facility: Ch de Pau
city: Perpignan
country: France
facility: Hopital Saint Jean
city: Pringy
country: France
facility: Ch de La Region Annnecienne
city: Saint Brieuc
country: France
facility: Ch Saint Brieuc
city: Saint Denis
country: France
facility: Ch de Saint Denis
city: Vannes
country: France
facility: Ch de Vannes
city: Villeneuve Saint Georges
country: France
facility: Chi Villeneauve Saint Georges
Study officials:
affiliation: CHR Orleans
name: Xavier CAUSSE
role: PRINCIPAL_INVESTIGATOR
References: