跳至主要内容
临床试验/NCT02809885
NCT02809885Unknown不适用

Hepatitis E Virus Infection in Pediatric Transplantation, a Prevalence Study

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2013年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
226
试验地点
2
主要终点
Hepatitis E virus prevalence in pediatric transplanted patients

研究概览

简要总结

Hepatitis E virus (HEV) is an emerging disease. The genotype 1 and 2 are predominant in Asia and Africa, and are responsible for recurrent epidemics. Genotype 3 is the main genotype found in Europe and North America and is responsible for sporadic infections except for travel associated diseases.

HEV had a principally asymptomatic form. However, it was recently demonstrated that it could lead to a chronic form, especially in immunosuppressed patients. Moreover, in liver transplanted patients the infection could mimic a rejection and lead to the loss of the transplant. In other immunosuppressed patients, chronic hepatitis lead to cirrhosis and its well-known complications (ascitis, digestive hemorrhage, liver failure...). There is a lack of information about the prevalence of this disease.

In Canada the incidence of HEV infection was high (15-86% for liver transplanted children with liver tests disturbed). In Germany the prevalence was lower: 3,2% in liver & kidney transplanted children whereas 7,4% in control. It was shown in a retrospective study that in liver (and liver+kidney) transplanted children the prevalence in Lyon was around 8,3%.

This study will determined in a prospective approach the HEV prevalence in kidney, lung, heart and bone marrow transplanted children in Lyon.

研究设计

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

入排标准

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

入选标准

  • <18 years old
  • transplantation (heart, kidney, lung or bone marrow)
  • protocol acceptance by family
  • social security available

排除标准

  • protocol rejection by family

研究组 & 干预措施

Transplanted patients

Experimental

All patients included are in the same arm.

干预措施: Hepatitis E serology (Biological)

结局指标

主要结局

Hepatitis E virus prevalence in pediatric transplanted patients

时间窗: 6 months

Hepatitis E virus (HEV) serology : IgG \& IgM, and PCR HEV. If serology is positive a second serology will be performed 6 months after in order to detect chronic infection.

次要结局

  • Correlation between HEV prevalence and the different types of transplantation(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验