NCT02645955

Brief Summary

Primary Purpose:

  1. 1.Evaluate the prevalence and incidence of HEV infection in MHD patients.
  2. 2.Compare differences of the prevalence and incidence between the MHD patients and the control. .

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
436

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.8 years

First QC Date

December 24, 2015

Last Update Submit

September 13, 2020

Conditions

Hepatitis E Virus Infection

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • risk factors of HEV infection

    up to 1 year after enrollment

Study Arms (2)

Control group, disease history

people who didn't have disease history of Maintenance Hemodialysis

The MHD patient group, diseases history

Maintenance Hemodialysis Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 each for the MHD patient group and the control group

You may qualify if:

  • Maintenance hemodialysis patients and healthy people as control
  • Can understand the study progress, willing to sign the informed consent and participate the study

You may not qualify if:

  • Has received HEV vaccines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jianjun Niu, M.Sc.

    Zhongshan Hospital Xiamen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice-president of School of public health

Study Record Dates

First Submitted

December 24, 2015

First Posted

January 5, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09