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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03524014
Other study ID # 2018-A00117-48
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2018
Est. completion date December 30, 2020

Study information

Verified date July 2018
Source Central Hospital, Nancy, France
Contact Evelyne SCHVOERER, Pr
Phone 0383155269
Email e.schvoerer@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 30, 2020
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Only advice for diagnosis and prevention
Only advice for diagnosis and prevention

Locations

Country Name City State
France Schvoerer Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-HEV IgM (qualitative assay); Guidelines to improve HEV detection by using the 2 virological assays 2 years
Primary HEV RNA (quantitative PCR assay) Guidelines to improve HEV detection by using the 2 virological assays 2 years