Follow-up of HBsAg Inactive Carriers Study

Study Overview
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Brief Summary
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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.

Official Title
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Follow-up of HBsAg Inactive Carriers Study

Conditions
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Hepatitis B

Intervention / Treatment
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* Other: inactive carrier


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Inactive carriers<br> | Other: inactive carrier<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers