Clinical Trial: Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title:

Brief Summary:

Primary Purpose:

  1. Evaluate the prevalence and incidence of HEV infection in MHD patients.
  2. Compare differences of the prevalence and incidence between the MHD patients and the control. .

Secondary purpose:

Analyze risk factors of HEV infection.


Detailed Summary: This is an Epidemiological study manufactured by Xiamen University. The primary purpose of this study is to evaluate the prevalence and incidence of HEV infection in MHD patients and to compare differences between the MHD patients and the control. The secondary purpose of this study is to analyze risk factors of the infection of HEV. There are two phases in this study. The first phase is a cross-sectional study. Approximately 200 MHD patients will be enrolled in MHD patient group, followed by control group's enrollment according to the age and gender of the MHD patient group. Blood samples and questionnaire were got at this time. Secondly, 100 enrolled volunteers in each group who is negative for HEV-IgM、HEV-IgG、HEV RNA will be introduced into the cohort study. The MHD patient group will been taken blood samples at an interval of 3 month until the 12th month after the first phase, however, the control group only need one blood sample at 12th month.
Sponsor: Jun Zhang

Current Primary Outcome:

  • prevalence of HEV infection [ Time Frame: up to 1 year after enrollment ]
    number and rate of participants with abnormal laboratory values in the MHD patients and the control;
  • new-infection rate of HEV infection [ Time Frame: up to 1 year after enrollment ]
    number and rate of the participants who's baseline laboratory value is normal and change to abnormal during the follow-up in the MHD patients and the control


Original Primary Outcome: Same as current

Current Secondary Outcome: risk factors of HEV infection [ Time Frame: up to 1 year after enrollment ]

the odd ratio(OR) and 95%CI of the factors such as age gender for HEV infection in the MHD patients and the control


Original Secondary Outcome: Same as current

Information By: Xiamen University

Dates:
Date Received: December 24, 2015
Date Started: June 2014
Date Completion: October 2016
Last Updated: July 13, 2016
Last Verified: December 2015