Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

436 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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

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Hepatitis E Virus Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group, disease history

people who didn't have disease history of Maintenance Hemodialysis

No interventions assigned to this group

The MHD patient group, diseases history

Maintenance Hemodialysis Patients

No interventions assigned to this group

Eligibility Criteria

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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