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临床试验/NCT02247752
NCT02247752已完成不适用

Follow-up of HBsAg Inactive Carriers Study

Centre Hospitalier Régional d'Orléans64 个研究点 分布在 1 个国家目标入组 619 人开始时间: 2014年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
619
试验地点
64
主要终点
Incidence of unfavourable liver events

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Incidence of unfavourable liver events

时间窗: 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 ".

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (64)

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