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CompletedNCT07729202KARU-HEPUpdated Jul 27, 2026

Prevalence of Hepatitis E During Follow-up Liver and Kidney Transplant Patients in Guadeloupe, French West Indies

An interventional study of Liver and Kidney transplanted patients in Hepatitis E, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Completed at 1 site in Guadeloupe. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 7 years 4 months after the study started (first participant enrolled Mar 2019, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Hepatitis E virus (HEV) common cause acute hepatitis in transplant recipients but it may also be responsible of chronic liver disease. Actually there is not data about the prevalence of HEV Hepatitis in French West indies. In this study, we will aim to evaluate prevalence of HEV in patients with liver and kidney transplantation in Guadeloupe. Since 2000, we observe an increase of incidence in France. Hepatitis E is responsible for acute hepatitis, and it was previously believed that HEV cannot be developed to chronic hepatitis. However, more recent reports show that have shown that 6 to 15,6 % of kidney transplant patients are positive for anti-HEV IgG. In addition, studies have shown that HEV infection is commonly observed in patients with transplantation of solid organs such as kidney, pancreas and liver. Patients with organ transplantation are more susceptible to diseases caused by rare infectious viruses such as HEV ; thus, differential diagnosis of pathogens such as hepatitis E virus in transplant recipients is suggested to be applied according to the reports showing that there is a relatively rapid progression to cirrhosis and chronic hepatitis E in people who have had organ transplants. We estimate that 400 patients are followed in our center in Guadeloupe for kidney or liver tranplantation. In this study, we will aim to evaluate the prevalence of HEV in patients kidney and liver transplantation. We will perfom for each patient : HEV serology and HEV viral load by PCR.

02

Conditions studied

  • Hepatitis E

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Keywords

  • Hepatitis E
  • Kidney transplant
  • liver transplants
  • transplants recipients
03

In context

Hepatitis E

37 studies on the registry are indexed under Hepatitis E; 9 are open to participants now.

This study's enrollment of 95 is below the median of 330 across 26 interventional studies indexed under Hepatitis E.

Browse Hepatitis E studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • minor
  • pregnant or breastfeeding women
  • vulnerable person
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Other
    Liver and Kidney transplanted patients

    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

  • OtherLiver and Kidney transplanted patients

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

06

What researchers measure

Primary outcomes

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

    percentage

    Time frame: 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

    percentage

    Time frame: At inclusion

07

Study locations

1 site
  • Centre Hospitalier Universitaire de la Guadeloupe
    Les Abymes, Guadeloupe 97159, Guadeloupe
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07729202
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Mar 22, 2019
Primary completion
May 5, 2019
Completion
May 9, 2019
Last update
Jul 27, 2026

Study contacts

Eric SAILLARD
principal investigator · CHU de la Guadeloupe

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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