Hepatitis EEVENCT06137313
Exposure to Hepatitis E Virus in Occitania, France
An observational study of Hepatitis E, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania. Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis E
- What is being tested?
- questionnaire
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2023to 14 Nov 2024
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult blood donors
Who may be able to join
- blood donors
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Purpan University Hospital
Toulouse, 31059
Jacques Izopet, MD, PhD, 567690422 ext. +33, izopet.j@chu-toulouse.fr
About this study
Official title: Determination of HEV Seroprevalence Among Blood Donors in Occitania
The objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania.
Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar
Read the detailed description
Hepatitis E virus (HEV) includes 4 major genotypes. It is now well established that HEV is endemic in most industrialized countries where it is transmitted zoonotically (genotypes 3 and 4) from a large animal reservoir, mainly pigs, unlike in resource-limited countries where it is is transmitted by water (genotypes 1 and 2 strictly human). The optimization of the use of virological tests and the improvement of epidemiological knowledge have led to the identification of a growing number of hepatitis E transmitted enterically but also through transfusion. While many infections are asymptomatic and self-limiting, immunocompromised people can develop chronic hepatitis which can progress to cirrhosis. Furthermore, people with pre-existing chronic hepatitis regardless of the etiology present, in the event of HEV infection, a risk of hepatic decompensation associated with high mortality. The diagnosis of HEV infection is based on both serological tests (anti-HEV IgM and anti-HEV IgG) and molecular tests (HEV RNA).
Although HEV transmission is mainly enteric, transmission by labile blood products (plasma, platelets, or red blood cells) has been documented in France and abroad. Given the endemic nature of HEV infection on a global scale and the very high frequency of asymptomatic infections, reducing the risk of HEV transmission by transfusion cannot be achieved by selecting donors from clinical or epidemiological criteria. Furthermore, pathogen mitigation processes are ineffective on HEV. As a result, biological screening for HEV has been implemented in different countries in Europe and Asia. In France, systematic screening of the HEV genome was introduced on March 20, 2023. All positive samples are sent to the HEV-hepatitis A virus (HAV) National Reference Center (Toulouse University Hospital Virology Laboratory) for quantification of the viral load, determination of the genotype and detection of anti-HEV antibodies (IgG and IgM). Donors screened positive for HEV-RNA are informed of the infection by a specific letter and invited to consult a General Practitioner. Hygiene measures are also recommended to prevent contamination of those around you due to viral excretion in the stools. They are deferred from donating for a period of 4 months corresponding to a maximum duration of viremia. An epidemiological questionnaire is completed by the donor and returned by mail to the French Blood Establishment.
Previous studies conducted more than 10 years ago among blood donors in Occitanie and at the national level showed that the Occitanie region was a region with high HEV seroprevalence (39%) but with differences ranging from 20% to more than 70% depending on the departments. Based on multivariate analyses, dietary habits such as consumption of pork or game do not explain the entire epidemiology of HEV in this region and other modes of transmission, notably by water, probably exist.
- Conditions
- Hepatitis E
- Being tested
- questionnaire
- Medical subject headings
- Hepatitis E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
completion of a questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of blood donors harbouring IgG anti-HEV
analysis of IgG anti-HEV in serum
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Dec 2023
- Primary completion15 Oct 2024 (estimated)
- Study completion14 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis EStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Izopet, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137313
- Sponsor's protocol ID
- RC31/23/0505
- Acronym
- EVE
- Status last verified
- May 2024
- First submitted
- 13 Nov 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of HEV Seroprevalence Among Blood Donors in Occitania
- ClinicalTrials.gov ID
- NCT06137313
- Acronym / sponsor ID
- EVE / RC31/23/0505
- Conditions
- Hepatitis E
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Oct 2024 (estimated)
- Study completion
- 14 Nov 2024 (estimated)
- First posted
- 18 Nov 2023 (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 objective of the proposed work is to determine the seroprevalence of HEV in 2023 in a population of blood donors living in Occitania.
Compare the current frequency of anti-HEV IgG and IgM markers with that of 2011. The serological techniques used and the questionnaires will be similar
Detailed description
Hepatitis E virus (HEV) includes 4 major genotypes. It is now well established that HEV is endemic in most industrialized countries where it is transmitted zoonotically (genotypes 3 and 4) from a large animal reservoir, mainly pigs, unlike in resource-limited countries where it is is transmitted by water (genotypes 1 and 2 strictly human). The optimization of the use of virological tests and the improvement of epidemiological knowledge have led to the identification of a growing number of hepatitis E transmitted enterically but also through transfusion. While many infections are asymptomatic and self-limiting, immunocompromised people can develop chronic hepatitis which can progress to cirrhosis. Furthermore, people with pre-existing chronic hepatitis regardless of the etiology present, in the event of HEV infection, a risk of hepatic decompensation associated with high mortality. The diagnosis of HEV infection is based on both serological tests (anti-HEV IgM and anti-HEV IgG) and molecular tests (HEV RNA).
Although HEV transmission is mainly enteric, transmission by labile blood products (plasma, platelets, or red blood cells) has been documented in France and abroad. Given the endemic nature of HEV infection on a global scale and the very high frequency of asymptomatic infections, reducing the risk of HEV transmission by transfusion cannot be achieved by selecting donors from clinical or epidemiological criteria. Furthermore, pathogen mitigation processes are ineffective on HEV. As a result, biological screening for HEV has been implemented in different countries in Europe and Asia. In France, systematic screening of the HEV genome was introduced on March 20, 2023. All positive samples are sent to the HEV-hepatitis A virus (HAV) National Reference Center (Toulouse University Hospital Virology Laboratory) for quantification of the viral load, determination of the genotype and detection of anti-HEV antibodies (IgG and IgM). Donors screened positive for HEV-RNA are informed of the infection by a specific letter and invited to consult a General Practitioner. Hygiene measures are also recommended to prevent contamination of those around you due to viral excretion in the stools. They are deferred from donating for a period of 4 months corresponding to a maximum duration of viremia. An epidemiological questionnaire is completed by the donor and returned by mail to the French Blood Establishment.
Previous studies conducted more than 10 years ago among blood donors in Occitanie and at the national level showed that the Occitanie region was a region with high HEV seroprevalence (39%) but with differences ranging from 20% to more than 70% depending on the departments. Based on multivariate analyses, dietary habits such as consumption of pork or game do not explain the entire epidemiology of HEV in this region and other modes of transmission, notably by water, probably exist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult blood donors
Key inclusion criteria (1 listed)
- blood donors
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| questionnairecompletion of a questionnaire | Other | – |
Primary outcome
Percentage of blood donors harbouring IgG anti-HEV
Time frame: at inclusion
analysis of IgG anti-HEV in serum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatitis E
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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.
Jacques Izopet, MD principal investigator
University Hospital, Toulouse
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, run by University Hospital, Toulouse 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 16 May 2024. 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 Jacques Izopet, MD (567690422 ext. +33, izopet.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of blood donors harbouring IgG anti-HEV (time frame: at inclusion). 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 16 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.