Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Seroprevalence of Hepatitis E in People With an Organ Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190253
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : December 16, 2021
Sponsor:
Collaborators:
Georgetown University
University of Pennsylvania
University of Wisconsin, Madison
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief 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.

Condition or disease
Hepatitis E

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 447 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Seroprevalence of anti-HEV [ Time Frame: Baseline ]
    Seroprevalence of antibody to hepatitis E IgG



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary referral center with liver transplant program
Criteria
  • 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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, District of Columbia
Georgetown University
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
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Georgetown University
University of Pennsylvania
University of Wisconsin, Madison
Investigators
Layout table for investigator information
Principal Investigator: Marc G Ghany, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Publications:
Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT02190253    
Other Study ID Numbers: 999914148
14-DK-N148
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: November 19, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Renal Threshold
Liver Transplant
Transplantation
Hepatitis E
Natural History
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis E
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections