NCT02645955

Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 436 (actual)
• Sponsor: Xiamen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis E Virus Infection

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-01-05
• Last updated: 2020-09-16