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Completed

NCT Number: NCT02645955

Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

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.

Completed

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Key information

Conditions

Hepatitis E Virus Infection Digestive System Diseases Hepatitis Hepatitis E Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. prevalence of HEV infection

    Time frame: up to 1 year after enrollment

    number and rate of participants with abnormal laboratory values in the MHD patients and the control;

  2. new-infection rate of HEV infection

    Time frame: up to 1 year after enrollment

    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

Secondary outcomes

  1. risk factors of HEV infection

    Time frame: up to 1 year after enrollment

    the odd ratio(OR) and 95%CI of the factors such as age gender for HEV infection in the MHD patients and the control

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Registry information

Acronym: MHD HEV

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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