Hepatitis E Infection in Humans and in EnvironmentVHENENCT03524014
Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.
An observational study of Hepatitis E Infection in Humans and in Environment, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis E Infection in Humans and in Environment
- What is being tested?
- Only advice for diagnosis and prevention
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms
Who cannot join
- Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Schvoerer
Vandœuvre-lès-Nancy, 54511
Evelyne SCHVOERER, Pr, 0383155269, e.schvoerer@chru-nancy.fr
About this study
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.
- Being tested
- Only advice for diagnosis and prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Only advice for diagnosis and preventionOther
Only advice for diagnosis and prevention
| Study group | Role | What they receive |
|---|---|---|
| HEV-infected patients with hepatitis | Not described Receives: Other: Only advice for diagnosis and prevention | |
| HEV-infected patients with neurological features | Not described Receives: Other: Only advice for diagnosis and prevention | |
| HEV-infected patients with kidney features | Not described Receives: Other: Only advice for diagnosis and prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HEV IgM (qualitative assay);
Guidelines to improve HEV detection by using the 2 virological assays
Measured: 2 years
HEV RNA (quantitative PCR assay)
Guidelines to improve HEV detection by using the 2 virological assays
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 May 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis E Infection in Humans and in EnvironmentStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524014
- Sponsor's protocol ID
- 2018-A00117-48
- Acronym
- VHENE
- Status last verified
- Jul 2018
- First submitted
- 18 Apr 2018
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis E Infection : Emergence Mechanisms in North-Eastern France of Polymorphic Clinical Forms.
- ClinicalTrials.gov ID
- NCT03524014
- Acronym / sponsor ID
- VHENE / 2018-A00117-48
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 14 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- HEV-infected patients, with hepatitis and/or neurological and/or renal symptoms
Key exclusion criteria (1 listed)
- Patients, with hepatitis and/or neurological and/or renal symptoms, infected by other viruses leading to hepatitis (hepatitis B, hepatitis C, hepatitis A ...)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Only advice for diagnosis and preventionOnly advice for diagnosis and prevention | Other | HEV-infected patients with hepatitis, HEV-infected patients with kidney features, HEV-infected patients with neurological features |
Primary outcome
Anti-HEV IgM (qualitative assay);
Time frame: 2 years
Guidelines to improve HEV detection by using the 2 virological assays
HEV RNA (quantitative PCR assay)
Time frame: 2 years
Guidelines to improve HEV detection by using the 2 virological assays
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis E Infection in Humans and in Environment, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyne SCHVOERER, Pr (0383155269 ext. +33, e.schvoerer@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HEV IgM (qualitative assay); (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.