Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients

Hepatitis E Virus Infection Clinical Trial

— MHD HEV  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645955
• Other study ID #: MHD-01
• Status: Completed
• Start date: May 2016
• Est. completion date: March 2018

Study information

• Verified date: September 2020
• Source: Xiamen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E
• Hepatitis E Virus Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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