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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Liver and Kidney transplanted patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patient with positive Hepatitis E serology and viral load by
percentage
Measured: 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
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start22 Mar 2019
- Primary completion5 May 2019
- Study completion9 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis EStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric SAILLARD, Principal investigator, CHU de la Guadeloupe
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