ClinicalTrials.gg
RecruitingNCT06137313EVEUpdated May 16, 2024

Exposure to Hepatitis E Virus in Occitania, France

An observational study in Hepatitis E, sponsored by University Hospital, Toulouse. Recruiting at 1 site in France. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-16.

Sponsored by University Hospital, Toulouse · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Dec 2023; still recruiting 2 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hepatitis E

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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 5,000 is above the median of 436 across 11 observational studies indexed under Hepatitis E.

Browse Hepatitis E studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

adult blood donors

Inclusion criteria

  • blood donors

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Otherquestionnaire

    completion of a questionnaire

06

What researchers measure

Primary outcomes

  1. Percentage of blood donors harbouring IgG anti-HEV

    analysis of IgG anti-HEV in serum

    Time frame: at inclusion

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2023 (actual). Primary completion is estimated for Oct 2024, 10 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2023
First posted
Nov 18, 2023
StartActual
Dec 15, 2023
Primary completionEst.
Oct 15, 2024
CompletionEst.
Nov 14, 2024
Last update
May 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06137313
Responsible party
Sponsor
First posted
Nov 18, 2023
Start date
Dec 15, 2023
Primary completion
Oct 15, 2024 (estimated)
Completion
Nov 14, 2024 (estimated)
Last update
May 16, 2024

Study contacts

Jacques Izopet, MD
Contact
izopet.j@chu-toulouse.fr
567690422 ext. +33
Jacques Izopet, MD
principal investigator · University Hospital, Toulouse

Oversight

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

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