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Hepatitis EKARU-HEPNCT07729202

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

A study testing Liver and Kidney transplanted patients in people with Hepatitis E, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis E
What is being tested?
Liver and Kidney transplanted patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteGuadeloupe
Study dates
22 Mar 2019to 9 May 2019
Phase
Interventional

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • minor
  • pregnant or breastfeeding women
  • vulnerable person

Trial locations and contacts

1 site in 1 country.

Guadeloupe1 site
  • Centre Hospitalier Universitaire de la Guadeloupe

    Les Abymes, Guadeloupe, 97159

Other trials in Guadeloupe

About this study

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.

Conditions
Hepatitis E
Being tested
Liver and Kidney transplanted patients
Keywords
Hepatitis E, Kidney transplant, liver transplants, transplants recipients
Medical subject headings
Hepatitis E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liver and Kidney transplanted patientsOther

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

Study groups in NCT07729202
Study groupRoleWhat they receive
Liver and Kidney transplanted patientsOther2 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.
Receives: Other: Liver and Kidney transplanted patients

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    percentage

    Measured: At inclusion

Secondary outcomes (1)
  1. percentage of patients with hepatitis E virus, according to the transmission mode that will be investigated during the questioning of the patient

    percentage

    Measured: At inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start22 Mar 2019
  3. Primary completion5 May 2019
  4. Study completion9 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07729202
Sponsor's protocol ID
PAP_RI2_2017/05
Acronym
KARU-HEP
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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