Seroprevalence of Hepatitis E in People With an Organ Transplant
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|ClinicalTrials.gov Identifier: NCT02190253|
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : December 16, 2021
- 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.
- To see how many patients who have received or are waiting for certain transplants have antibodies to hepatitis E virus.
- 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.
- 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|
|Study Type :||Observational|
|Actual Enrollment :||447 participants|
|Official Title:||Seroprevalence of Hepatitis E in The Organ Transplant Subjects|
|Actual Study Start Date :||July 12, 2014|
|Actual Primary Completion Date :||February 5, 2019|
|Actual Study Completion Date :||February 5, 2019|
Organ transplant recipients
Recipients of either liver, kidney, liver and kidney, and small bowel transplants
Patients on waitlist for liver, kidney or intestinal transplantation
- Seroprevalence of anti-HEV [ Time Frame: Baseline ]Seroprevalence of antibody to hepatitis E IgG
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190253
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007-2197|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-6056|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Marc G Ghany, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|