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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hepatitis E During Follow-up Liver and Kidney Transplant Patients in Guadeloupe, French West Indies
- ClinicalTrials.gov ID
- NCT07729202
- Acronym / sponsor ID
- KARU-HEP / PAP_RI2_2017/05
- Conditions
- Hepatitis E
- Keywords
- Hepatitis E, Kidney transplant, liver transplants, transplants recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 9 May 2019 (actual)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Liver and Kidney transplanted patients | Other | Other: Liver and Kidney transplanted patients2 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age above 18 years
- patients with liver or kidney transplant
- health insurance
Key exclusion criteria (3 listed)
- minor
- pregnant or breastfeeding women
- vulnerable person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver and Kidney transplanted patients2 tube samples will be collected for the PCR test and the hepatitis E serology. | Other | Liver and Kidney transplanted patients |
Primary outcome
percentage of patient with positive Hepatitis E serology and viral load by
Time frame: At inclusion
percentage
1 secondary outcome
percentage of patients with hepatitis E virus, according to the transmission mode that will be investigated during the questioning of the patient
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric SAILLARD principal investigator
CHU de la Guadeloupe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patient with positive Hepatitis E serology and viral load by (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.