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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis E Virus 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 Type: Observational
• Enrollment (Actual): 436

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

200 each for the MHD patient group and the control group

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group, disease history; people who didn't have disease history of Maintenance Hemodialysis
The MHD patient group, diseases history; Maintenance Hemodialysis Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of HEV infection	number and rate of participants with abnormal laboratory values in the MHD patients and the control;	up to 1 year after enrollment
new-infection rate of HEV infection	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	up to 1 year after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors of HEV infection	the odd ratio(OR) and 95%CI of the factors such as age gender for HEV infection in the MHD patients and the control	up to 1 year after enrollment

Collaborators and Investigators

• Sponsor: Xiamen University
• Investigators: Principal Investigator: Jianjun Niu, M.Sc., Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: December 24, 2015
• First Submitted That Met QC Criteria: January 3, 2016
• First Posted (Estimate): January 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis E
• Other Study ID Numbers: MHD-01