Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients (MHD HEV)

Xiamen University

Status

Completed

Conditions

Hepatitis E Virus Infection

Study type

Observational

Funder types

Other

Identifiers

NCT02645955

MHD-01

Details and patient eligibility

About

Primary Purpose:

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

Secondary purpose:

Analyze risk factors of HEV infection.

Full 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.

Enrollment

436 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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