Status:
COMPLETED
Follow-up of HBsAg Inactive Carriers Study
Lead Sponsor:
Centre Hospitalier Régional d'Orléans
Collaborating Sponsors:
INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF
Faculté de mathématiques ORLEANS
Conditions:
Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
NA
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 carri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2022
Estimated Enrollment :
619 Patients enrolled
Trial Details
Trial ID
NCT02247752
Start Date
September 16 2014
End Date
February 4 2022
Last Update
April 6 2022
Active Locations (32)
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1
Ch General Du Pays D'Aix
Aix-en-Provence, France, 13616
2
CH d'AVIGNON
Avignon, France, 84902
3
Clinique de La Chataigneraie
Beaumont, France, 63110
4
Medical Center Besancon
Besançon, France, 25000