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| ID | Type | Description | Link |
|---|---|---|---|
| 14-DK-N148 |
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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| University of Pennsylvania | OTHER |
| University of Wisconsin, Madison | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Seroprevalence of anti-HEV | Seroprevalence of antibody to hepatitis E IgG | Baseline |
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Inclusion criteria for post-transplant subjects
Exclusion criteria for post-transplant subjects:
Inclusion criteria for waitlist subjects:
Exclusion criteria for waitlist subjects:
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Tertiary referral center with liver transplant program
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| Name | Affiliation | Role |
|---|---|---|
| Marc G Ghany, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University | Washington D.C. | District of Columbia | 20007-2197 | United States | ||
| University of Pennsylvania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20485250 | Background | Pischke S, Wedemeyer H. Chronic hepatitis E in liver transplant recipients: a significant clinical problem? Minerva Gastroenterol Dietol. 2010 Jun;56(2):121-8. | |
| 19157619 | Background | 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. |
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| ID | Term |
|---|---|
| D016751 | Hepatitis E |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| Philadelphia |
| Pennsylvania |
| 19104-6056 |
| United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 19790147 | Background | 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. |
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |