Hepatitis E Clinical Trial
Official title:
Seroprevalence of Hepatitis E in The Organ Transplant Subjects
Verified date | June 4, 2024 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 447 |
Est. completion date | February 5, 2019 |
Est. primary completion date | February 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Georgetown University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Georgetown University, University of Pennsylvania, University of Wisconsin, Madison |
United States,
Gerolami R, Moal V, Picard C, Colson P. Hepatitis E virus as an emerging cause of chronic liver disease in organ transplant recipients. J Hepatol. 2009 Mar;50(3):622-4. doi: 10.1016/j.jhep.2008.12.008. Epub 2008 Dec 25. No abstract available. — View Citation
Haagsma EB, Niesters HG, van den Berg AP, Riezebos-Brilman A, Porte RJ, Vennema H, Reimerink JH, Koopmans MP. Prevalence of hepatitis E virus infection in liver transplant recipients. Liver Transpl. 2009 Oct;15(10):1225-8. doi: 10.1002/lt.21819. — View Citation
Pischke S, Wedemeyer H. Chronic hepatitis E in liver transplant recipients: a significant clinical problem? Minerva Gastroenterol Dietol. 2010 Jun;56(2):121-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroprevalence of anti-HEV | Seroprevalence of antibody to hepatitis E IgG | Baseline |
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