跳至主要内容
临床试验/NCT04670419
NCT04670419已完成不适用

Morbidity and Mortality of Hepatitis E Virus Infections in Belgium 2010-2018

University Hospital, Antwerp0 个研究点目标入组 280 人开始时间: 2010年1月1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
280
主要终点
HEV viral factors associated with morbidity and mortality

研究概览

简要总结

Hepatitis E Virus (HEV) infections are emerging in the Western world with a predominance of HEV genotype (gt) 3. Except for age older than 50 years, male gender, chronic liver disease and immunosuppressed status, no correlators with clinical outcomes have been identified so far. With this study, we want to examine viral factors associated with the morbidity and mortality of HEV infections in Belgium as well as find correlators with clinical outcomes.

详细描述

  1. Study objectives

1.1. Primary objectives:

To examine viral factors, such as gt, subtype and viral load, associated with the morbidity and mortality of HEV infections in Belgium.

1.2. Secondary objectives:

  • To describe host factors associated with the morbidity and mortality of HEV infections in Belgium.
  • To find independent host and/or viral factors that are associated with the morbidity and mortality of HEV infections in Belgium.
  1. Investigational plan

2.1. General study design

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • HEV RNA positive AND/OR HEV immunoglobulin (Ig)M positive
  • Lab confirmation of the HEV infection performed at Sciensano
  • All ages will be included
  • Referring hospital in Belgium

排除标准

  • No confirmation of HEV serology AND/OR polymerase chain reaction (PCR) performed at Sciensano
  • Cases not diagnosed in Belgium
  • Cases without clinical outcome data

结局指标

主要结局

HEV viral factors associated with morbidity and mortality

时间窗: observation period 2010-2018

Viral factors, such as genotype, subtype and viral load, associated with the morbidity and mortality of HEV infections in Belgium

次要结局

  • Host factors associated with the morbidity and mortality of HEV infections in Belgium.(observation period 2010-2018)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Vanwolleghem

Prof. Dr.

University Hospital, Antwerp

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