An observational study in Hepatitis E Virus Infection, sponsored by Xiamen University. Completed. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Xiamen University · Observational
Primary Purpose:
Secondary purpose:
Analyze risk factors of HEV infection.
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.
37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.
This study's enrollment of 436 is close to the median of 436 across 11 observational studies indexed under Hepatitis E.
Browse Hepatitis E studies →Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
200 each for the MHD patient group and the control group
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
people who didn't have disease history of Maintenance Hemodialysis
Maintenance Hemodialysis Patients
prevalence of HEV infection
number and rate of participants with abnormal laboratory values in the MHD patients and the control;
Time frame: 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
Time frame: up to 1 year after enrollment
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
Time frame: up to 1 year after enrollment
No study locations are listed for this record.
The record gives a start of May 2016, a primary completion of Mar 2018 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Xiamen University