Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Completed

• Conditions: Hepatitis E Virus Infection

• Registration Number: NCT02645955
• Lead Sponsor: Xiamen University

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 Description

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.

Study Timeline

• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2016-01-03
• Study First Posted: 2016-01-05
• Study Start: 2016-05
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-13
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• Maintenance hemodialysis patients and healthy people as control
• Can understand the study progress, willing to sign the informed consent and participate the study

Exclusion Criteria

• Has received HEV vaccines

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of HEV infection	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	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

Secondary Outcome Measures

Name	Time	Method
risk factors of HEV infection	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