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

• Conditions: Hepatitis E Infection in Humans and in Environment

• Registration Number: NCT03524014
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-18
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-14
• Study Start: 2018-05-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18
• Primary Completion: 2019-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HEV RNA (quantitative PCR assay)	2 years	Guidelines to improve HEV detection by using the 2 virological assays
Anti-HEV IgM (qualitative assay);	2 years	Guidelines to improve HEV detection by using the 2 virological assays

Trial Locations

Locations (1)

Schvoerer; 🇫🇷 Vandoeuvre Les Nancy, France