NCT07729202

Brief Summary

Hepatitis E is well known to be a common cause of severe hepatitis on organ-transplanted people. However, several studies also show a risk of transition to a chronic state. It is necessary to carry out a preliminary study in order to determine the hepatitis E prevalence in the population of the French West Indies. The aim of our study is to make a systematic screening of the hepatitis E within this risk population; hepatic and renal transplanted people. Up to now, no severe hepatitis E case was reported in the French West Indies. We would like to know if the systematic screening will change or not, this assumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2019

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2026

Completed
Last Updated

July 27, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 22, 2026

Last Update Submit

July 22, 2026

Conditions

Keywords

Hepatitis EKidney transplantliver transplantstransplants recipients

Outcome Measures

Primary Outcomes (1)

  • percentage of patient with positive Hepatitis E serology and viral load by

    percentage

    At inclusion

Secondary Outcomes (1)

  • percentage of patients with hepatitis E virus, according to the transmission mode that will be investigated during the questioning of the patient

    At inclusion

Study Arms (1)

Liver and Kidney transplanted patients

OTHER

2 tube samples will be collected for the PCR test and the hepatitis E serology. Moreover, 2 tube samples will be collected for the plasma, cell and DNA collection and 1 tube sample will be collected for the serum collection.

Other: Liver and Kidney transplanted patients

Interventions

2 tube samples will be collected for the PCR test and the hepatitis E serology.

Liver and Kidney transplanted patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18 years
  • patients with liver or kidney transplant
  • health insurance

You may not qualify if:

  • minor
  • pregnant or breastfeeding women
  • vulnerable person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Les Abymes, Guadeloupe, 97159, Guadeloupe

Location

MeSH Terms

Conditions

Hepatitis E

Interventions

Liver Extracts

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Tissue ExtractsComplex Mixtures

Study Officials

  • Eric SAILLARD

    CHU de la Guadeloupe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: There will be a single group. Indeed, only liver and/or kidney transplanted patients, living in the GUADELOUPE French West Indies will be included in the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 27, 2026

Study Start

March 22, 2019

Primary Completion

May 5, 2019

Study Completion

May 9, 2019

Last Updated

July 27, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations