NCT02247752

Follow-up of HBsAg Inactive Carriers Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 619 (actual)
• Sponsor: Centre Hospitalier Régional d'Orléans · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-09-16
• Primary completion: 2016-03-31
• Completion: 2022-02-04
• First posted: 2014-09-25
• Last updated: 2022-04-06

Locations

32 sites across 1 country: France