Overview

This trial is active, not recruiting.

Condition hepatitis e virus infection
Sponsor Jun Zhang
Start date June 2014
End date August 2016
Trial size 436 participants
Trial identifier NCT02645955, MHD-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
people who didn't have disease history of Maintenance Hemodialysis
Maintenance Hemodialysis Patients

Primary Outcomes

Measure
prevalence of HEV infection
time frame: up to 1 year after enrollment
new-infection rate of HEV infection
time frame: up to 1 year after enrollment

Secondary Outcomes

Measure
risk factors of HEV infection
time frame: up to 1 year after enrollment

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Principal investigator Jianjun Niu, M.Sc.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Xiamen University.