Follow-up of HBsAg Inactive Carriers Study

Hepatitis B Clinical Trial

— PIBAC  

Official title:

Follow-up of HBsAg Inactive Carriers Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02247752
• Other study ID #: CHRO -2014-02
• Status: Completed
• Phase: N/A
• Start date: September 16, 2014
• Est. completion date: February 4, 2022

Study information

• Verified date: April 2022
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: February 4, 2022
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

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.

Locations

Country	Name	City	State
France	Ch General Du Pays D'Aix	Aix en Provence
France	CH d'AVIGNON	Avignon
France	Clinique de La Chataigneraie	Beaumont
France	Medical Center Besancon	Besancon
France	Clinical Center Bourgoin Jallieu	Bourgoin Jallieu
France	Hopital Sainte Camille	Bry sur Marne
France	Ch de Caen	Caen
France	Ch Sud Fracilien Jean Jaures	Corbeil essonnes
France	CH CREIL	Creil
France	Ch de Creteil	Creteil
France	CH de GONESSE	Gonesse
France	Clinique Du Palais	Grasse
France	Ch D'Hyeres	Hyeres
France	Ch de Lagny Marne La Valee	Jossigny
France	Chd Vendee	La Roche sur yon
France	Ch Du Mans	Le Mans
France	Medical Center La Sauvegarde	Lyon
France	Ch de Meaux	Meaux
France	CH MELUN	Melun
France	Ch Montelimar	Montelimar
France	Ch de Montfermeil	Montfermeil
France	Clinical Center Montpellier	Montpellier
France	Medical Center Nanterre	Nanterre
France	CHR d'ORLEANS	Orleans
France	Medical Center Paris 7	Paris
France	Ch de Pau	Pau
France	Hopital Saint Jean	Perpignan
France	Ch de La Region Annnecienne	Pringy
France	Ch Saint Brieuc	Saint Brieuc
France	Ch de Saint Denis	Saint Denis
France	Ch de Vannes	Vannes
France	Chi Villeneauve Saint Georges	Villeneuve Saint Georges

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans	Faculté de mathématiques ORLEANS, INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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