NCT06137313

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
27 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

10 months

First QC Date

November 13, 2023

Last Update Submit

May 13, 2024

Conditions

Hepatitis E

Outcome Measures

Primary Outcomes (1)

  • Percentage of blood donors harbouring IgG anti-HEV

    analysis of IgG anti-HEV in serum

    at inclusion

Interventions

questionnaireOTHER

completion of a questionnaire

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult blood donors

You may qualify if:

  • blood donors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purpan University Hospital

Toulouse, 31059, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hepatitis E

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jacques Izopet, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Izopet, MD

CONTACT

567690422izopet.j@chu-toulouse.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

December 15, 2023

Primary Completion

October 15, 2024

Study Completion

November 14, 2024

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)