Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms. (VHENE)

July 16, 2018 updated by: Central Hospital, Nancy, France
The present research aims to collect virological and clinical data on hepatitis E virus (HEV) infections, either in acute or chronic forms of HEV infection in North-Eastern France, with liver- or non liver-related symptoms, plus data on HEV circulation in the outside environment. The purpose of this study is to improve the diagnosis and care of HEV-infected patients, as well as the preventive features to take into account in order to avoid food- and environment-borne infections. At last, we will investigate HEV molecular characteristics, with the hypothesis that some advantageous HEV strains coul be more pathogenic for some tissues and/or organs.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusions during 2 years (2018-2019):

  • HEV infection, liver-related syndroms (either acute or chronic), n=20
  • HEV-infection, neurological (n=5; controls n=5) or renal syndroms (5-10; controls n= 5-10)

Description

Inclusion Criteria:

  • HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms

Exclusion Criteria:

  • Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HEV-infected patients with hepatitis
Other: Only advice for diagnosis and prevention
Only advice for diagnosis and prevention
HEV-infected patients with neurological features
Other: Only advice for diagnosis and prevention
Only advice for diagnosis and prevention
HEV-infected patients with kidney features
Other: Only advice for diagnosis and prevention
Only advice for diagnosis and prevention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-HEV IgM (qualitative assay);
Time Frame: 2 years
Guidelines to improve HEV detection by using the 2 virological assays
2 years
HEV RNA (quantitative PCR assay)
Time Frame: 2 years
Guidelines to improve HEV detection by using the 2 virological assays
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

April 18, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A00117-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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