ClinicalTrials.gg
Status unknownNCT03524014VHENEUpdated Jul 18, 2018

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

An observational study in Hepatitis E Infection in Humans and in Environment, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-18.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Hepatitis E Infection in Humans and in Environment

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03

In context

Hepatitis E

37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.

This study's planned enrollment of 40 is below the median of 436 across 11 observational studies indexed under Hepatitis E.

Browse Hepatitis E studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (, , hepatitis A ...)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • HEV-infected patients with hepatitis

    Other: Only advice for diagnosis and prevention

  • HEV-infected patients with neurological features

    Other: Only advice for diagnosis and prevention

  • HEV-infected patients with kidney features

    Other: Only advice for diagnosis and prevention

Interventions

  • OtherOnly advice for diagnosis and prevention

    Only advice for diagnosis and prevention

06

What researchers measure

Primary outcomes

  1. Anti-HEV IgM (qualitative assay);

    Guidelines to improve HEV detection by using the 2 virological assays

    Time frame: 2 years

  2. HEV RNA (quantitative PCR assay)

    Guidelines to improve HEV detection by using the 2 virological assays

    Time frame: 2 years

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Study locations

1 of 1 sites recruiting
  • Schvoerer
    Vandoeuvre Les Nancy, 54511, France
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03524014
Responsible party
Sponsor
First posted
May 14, 2018
Start date
May 15, 2018
Primary completion
Jun 30, 2019 (estimated)
Completion
Dec 30, 2020 (estimated)
Last update
Jul 18, 2018

Study contacts

Evelyne SCHVOERER, Pr
Contact
e.schvoerer@chru-nancy.fr
0383155269 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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