跳至主要内容
临床试验/NCT07729202
NCT07729202已完成不适用

Prevalence of Hepatitis E During Follow-up Liver and Kidney Transplant Patients in Guadeloupe, French West Indies

Centre Hospitalier Universitaire de la Guadeloupe1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
percentage of patient with positive Hepatitis E serology and viral load by

研究概览

简要总结

Hepatitis E is well known to be a common cause of severe hepatitis on organ-transplanted people. However, several studies also show a risk of transition to a chronic state. It is necessary to carry out a preliminary study in order to determine the hepatitis E prevalence in the population of the French West Indies. The aim of our study is to make a systematic screening of the hepatitis E within this risk population; hepatic and renal transplanted people. Up to now, no severe hepatitis E case was reported in the French West Indies.

We would like to know if the systematic screening will change or not, this assumption.

详细描述

Hepatitis E virus (HEV) common cause acute hepatitis in transplant recipients but it may also be responsible of chronic liver disease. Actually there is not data about the prevalence of HEV Hepatitis in French West indies. In this study, we will aim to evaluate prevalence of HEV in patients with liver and kidney transplantation in Guadeloupe. Since 2000, we observe an increase of incidence in France. Hepatitis E is responsible for acute hepatitis, and it was previously believed that HEV cannot be developed to chronic hepatitis. However, more recent reports show that have shown that 6 to 15,6 % of kidney transplant patients are positive for anti-HEV IgG. In addition, studies have shown that HEV infection is commonly observed in patients with transplantation of solid organs such as kidney, pancreas and liver. Patients with organ transplantation are more susceptible to diseases caused by rare infectious viruses such as HEV ; thus, differential diagnosis of pathogens such as hepatitis E virus in transplant recipients is suggested to be applied according to the reports showing that there is a relatively rapid progression to cirrhosis and chronic hepatitis E in people who have had organ transplants. We estimate that 400 patients are followed in our center in Guadeloupe for kidney or liver tranplantation. In this study, we will aim to evaluate the prevalence of HEV in patients kidney and liver transplantation. We will perfom for each patient : HEV serology and HEV viral load by PCR.

研究设计

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

入排标准

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

入选标准

  • age above 18 years
  • patients with liver or kidney transplant
  • health insurance

排除标准

  • pregnant or breastfeeding women
  • vulnerable person

结局指标

主要结局

percentage of patient with positive Hepatitis E serology and viral load by

时间窗: At inclusion

percentage

次要结局

  • percentage of patients with hepatitis E virus, according to the transmission mode that will be investigated during the questioning of the patient(At inclusion)

研究者

发起方
Centre Hospitalier Universitaire de la Guadeloupe
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验