Hepatitis E Virus InfectionMHD HEVNCT02645955
Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients
An observational study of Hepatitis E Virus Infection, run by Xiamen University.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E Virus Infection
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Mar 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 200 each for the MHD patient group and the control group
Who may be able to join
- Maintenance hemodialysis patients and healthy people as control
- Can understand the study progress, willing to sign the informed consent and participate the study
Who cannot join
- Has received HEV vaccines
About this study
Primary Purpose:
- Evaluate the prevalence and incidence of HEV infection in MHD patients.
- Compare differences of the prevalence and incidence between the MHD patients and the control. .
Secondary purpose:
Analyze risk factors of HEV infection.
Read the 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.
- Conditions
- Hepatitis E Virus Infection
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
prevalence of HEV infection
number and rate of participants with abnormal laboratory values in the MHD patients and the control;
Measured: 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
Measured: up to 1 year after enrollment
Secondary outcomes (1)
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
Measured: up to 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis E Virus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 436 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Xiamen University
- Investigators
- Jianjun Niu, M.Sc., Principal investigator, Zhongshan Hospital Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645955
- Sponsor's protocol ID
- MHD-01
- Acronym
- MHD HEV
- Status last verified
- Sep 2020
- First submitted
- 24 Dec 2015
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Hepatitis E Virus in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02645955
- Acronym / sponsor ID
- MHD HEV / MHD-01
- Conditions
- Hepatitis E Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Purpose:
- Evaluate the prevalence and incidence of HEV infection in MHD patients.
- Compare differences of the prevalence and incidence between the MHD patients and the control. .
Secondary purpose:
Analyze risk factors of HEV 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group, disease history | – | –people who didn't have disease history of Maintenance Hemodialysis |
| The MHD patient group, diseases history | – | –Maintenance Hemodialysis Patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 200 each for the MHD patient group and the control group
Key inclusion criteria (2 listed)
- Maintenance hemodialysis patients and healthy people as control
- Can understand the study progress, willing to sign the informed consent and participate the study
Key exclusion criteria (1 listed)
- Has received HEV vaccines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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;
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
1 secondary outcome
risk factors of HEV infection
Time frame: up to 1 year after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianjun Niu, M.Sc. principal investigator
Zhongshan Hospital Xiamen University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis E Virus Infection, run by Xiamen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of HEV infection (time frame: up to 1 year after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.