Seroprevalence of Hepatitis E in People With an Organ Transplant
Condition: Hepatitis E
MeSH terms: Hepatitis A; Hepatitis E; Hepatitis
Study type: Observational

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.
    

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 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.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary referral center with liver transplant program
      
Keywords: Renal Threshold; Liver Transplant; Transplantation; Hepatitis E; Natural History