Seroprevalence of Hepatitis E in People With an Organ Transplant

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT02190253

Collaborator

Georgetown University (Other), University of Pennsylvania (Other), University of Wisconsin, Madison (Other)

447

Enrollment

Locations

54.8

Actual Duration (Months)

149

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis E

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 Design

Study Type:

Observational

Actual Enrollment :

447 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Seroprevalence of Hepatitis E in The Organ Transplant Subjects

Actual Study Start Date :

Jul 12, 2014

Actual Primary Completion Date :

Feb 5, 2019

Actual Study Completion Date :

Feb 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Seroprevalence of anti-HEV [Baseline]
Seroprevalence of antibody to hepatitis E IgG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown University	Washington	District of Columbia	United States	20007-2197
2	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-6056
3	University of Wisconsin	Madison	Wisconsin	United States	53792