Seroprevalence of Hepatitis E in People With an Organ Transplant (NCT02190253) | Clinical Trial Compass
CompletedNot Applicable
Seroprevalence of Hepatitis E in People With an Organ Transplant
United States447 participantsStarted 2014-07-12
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroprevalence of anti-HEV
Timeframe: Baseline
Trial details
NCT IDNCT02190253
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)