Status:
COMPLETED
Seroprevalence of Hepatitis E in People With an Organ Transplant
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Georgetown University
University of Pennsylvania
Conditions:
Hepatitis E
Eligibility:
All Genders
18-100 years
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 hepati...
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 sub...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 12 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 5 2019
Estimated Enrollment :
447 Patients enrolled
Trial Details
Trial ID
NCT02190253
Start Date
July 12 2014
End Date
February 5 2019
Last Update
November 21 2025
Active Locations (3)
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1
Georgetown University
Washington D.C., 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