Seroprevalence of Hepatitis E in People With an Organ Transplant

September 30, 2023 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Seroprevalence of Hepatitis E in The Organ Transplant Subjects

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

447

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007-2197
        • Georgetown University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-6056
        • University of Pennsylvania
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Tertiary referral center with liver transplant program

Description

  • 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

Exclusion criteria for waitlist subjects:

  • Current or previous treatment within the last year with peg-interferon and or ribavirin.
  • Current immunosuppression
  • Known history of hepatitis E infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Organ transplant recipients
Recipients of either liver, kidney, liver and kidney, and small bowel transplants
Waitlist patients
Patients on waitlist for liver, kidney or intestinal transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroprevalence of anti-HEV
Time Frame: Baseline
Seroprevalence of antibody to hepatitis E IgG
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of Pennsylvania
Georgetown University
University of Wisconsin, Madison

Investigators

  • Principal Investigator: Marc G Ghany, M.D., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2014

Primary Completion (Actual)

February 5, 2019

Study Completion (Actual)

February 5, 2019

Study Registration Dates

First Submitted

July 12, 2014

First Submitted That Met QC Criteria

July 12, 2014

First Posted (Estimated)

July 15, 2014

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

June 30, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 999914148
  • 14-DK-N148

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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