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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03524014
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 31.5
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis E Infection in Humans and in Environment	Other: Only advice for diagnosis and prevention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.
• Actual Study Start Date: May 15, 2018
• Anticipated Primary Completion Date: Jun 30, 2019
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Anti-HEV IgM (qualitative assay); [2 years]

   Guidelines to improve HEV detection by using the 2 virological assays

2. HEV RNA (quantitative PCR assay) [2 years]

   Guidelines to improve HEV detection by using the 2 virological assays

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 ...)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schvoerer	Vandoeuvre Les Nancy		France	54511

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT03524014
• Other Study ID Numbers: 2018-A00117-48
• First Posted: May 14, 2018
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis E; Hepatitis

Study Results

No Results Posted as of Jul 18, 2018