Follow-up of HBsAg Inactive Carriers Study

Not Applicable

Completed

• Conditions: Hepatitis B
• Interventions: Other: inactive carrier

• Registration Number: NCT02247752
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-15
• Study Start: 2014-09-16
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-25
• Primary Completion: 2016-03-31
• Study Completion: 2022-02-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inactive carriers	inactive carrier	-

Primary Outcome Measures

Name	Time	Method
Incidence of unfavourable liver events	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 ".

Trial Locations

Locations (32)

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 de Lagny Marne La Valee; 🇫🇷 Jossigny, France

Ch D'Hyeres; 🇫🇷 Hyeres, 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 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, France

CH MELUN; 🇫🇷 Melun, France