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Seroprevalence of Hepatitis E in People With an Organ Transplant

Seroprevalence of Hepatitis E in The Organ Transplant Subjects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02190253
Enrollment
447
Registered
2014-07-15
Start date
2014-07-12
Completion date
2019-02-05
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis E

Keywords

Renal Threshold, Liver Transplant, Transplantation, Hepatitis E, Natural History

Brief summary

Background: \- The hepatitis E virus causes an acute hepatitis that usually goes away by itself. Researchers in France studied people who received a liver or kidney transplant. They found that hepatitis E may not go away by itself in these people. It becomes chronic. This can cause serious liver disease. More than half the people who had organ transplant who had hepatitis E seemed to get a chronic infection. Researchers want to find out if hepatitis E happens this often in patients who have liver, kidney, or small bowel transplants in the United States. If it does, they want to know why. They want to know if chronic hepatitis E will become an important medical problem. This research might help improve care for people who have a transplant. It also might help researchers prevent the spread of hepatitis E. Objective: \- To see how many patients who have received or are waiting for certain transplants have antibodies to hepatitis E virus. Eligibility: \- Adults over age 18 who have had a liver, kidney, liver and kidney, or small bowel transplant, or are on a waiting list for one. Design: * Participants will be enrolled from 3 transplant centers. * Participants will complete a questionnaire. They will be asked about possible risk factors for hepatitis E exposure. * Participants will have a blood sample drawn through a needle placed in a vein.

Detailed description

Hepatitis E virus infection commonly presents as an acute self-limiting hepatitis in the developing world. However there have been reports that chronic hepatitis E may develop in immunocompromised subjects such as renal and liver transplant recipients. Progression to cirrhosis has also been reported in patients with chronic hepatitis E infection. We hypothesize that immunosuppression post-organ transplantation predisposes individuals to increased susceptibility to hepatitis E infection. Therefore, in this study, we wish to determine the seroprevalence of antibody to hepatitis E IgG in organ transplant recipients (an immunosuppressed population) and compare it to patients who are on organ transplant waitlist (not immunosuppressed). We plan to study samples and date from 300 organ transplant recipients and 300 patients on waitlist for liver, kidney or intestinal transplantation and control for age, gender, organ and transplant center. Three transplant centers (2 in the mid-Atlantic area and one in the Mid-West) will each enroll 100 cases and controls. A minimum of 50 cases at each site will be liver transplant recipients. Cases will be stratified based on number of years post transplant one, two or greater than or equal to three years. Consecutive patients who are eligible and agree to participate in the study will be enrolled. A brief questionnaire to assess risk factors for acquisition of hepatitis E will be administered and 8mls of blood will be drawn in a serum separator tube for anti HEV IgG, anti HEV IgM and HEV RNA testing analysis at the NIH. Subjects who are confirmed to have acute or chronic HEV infection will be managed according to standard of care at each respective transplant centers.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Lead SponsorNIH
Georgetown University
CollaboratorOTHER
University of Pennsylvania
CollaboratorOTHER
University of Wisconsin, Madison
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* ELIGIBILITY CRITERIA: Inclusion criteria for post-transplant subjects * Age greater than or equal to 18 years, male or female * Recipients of either liver, kidney, liver and kidney, and small bowel transplants * Survival for a minimum of 1 year post-transplant * Willingness to provide written, informed consent

Exclusion criteria

for post-transplant subjects: * Current or previous treatment within the last year with peg-interferon and or ribavirin. * Known history of hepatitis E infection. Inclusion criteria for waitlist subjects: * Age greater than or equal to 18 years, male or female * Subjects on the waitlist for first liver, kidney, liver and kidney or small bowel transplant * Willingness to provide written, informed consent

Design outcomes

Primary

MeasureTime frameDescription
Seroprevalence of anti-HEVBaselineSeroprevalence of antibody to hepatitis E IgG

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMarc G Ghany, M.D.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026