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Completed

NCT Number: NCT07729202

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de la Guadeloupe

Les Abymes, Guadeloupe, 97159

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • minor
  • pregnant or breastfeeding women
  • vulnerable person

Treatment and study plan

Liver and Kidney transplanted patients

Other

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

Primary outcomes

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

    Time frame: At inclusion

    percentage

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

    Time frame: At inclusion

    percentage

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Other

Registry information

Acronym: KARU-HEP

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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