NCT02190253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

July 12, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
Last Updated

May 4, 2026

Status Verified

April 30, 2026

Enrollment Period

4.6 years

First QC Date

July 12, 2014

Last Update Submit

May 1, 2026

Conditions

Hepatitis E

Keywords

Renal ThresholdLiver TransplantTransplantationHepatitis ENatural History

Outcome Measures

Primary Outcomes (1)

  • Seroprevalence of anti-HEV

    Seroprevalence of antibody to hepatitis E IgG

    Baseline

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral center with liver transplant program

You may qualify if:

  • 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

You may not qualify if:

  • Current or previous treatment within the last year with peg-interferon and or ribavirin.
  • Known history of hepatitis E infection.
  • 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
  • Current or previous treatment within the last year with peg-interferon and or ribavirin.
  • Current immunosuppression
  • Known history of hepatitis E infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Georgetown University

Washington D.C., District of Columbia, 20007-2197, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6056, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (3)

  • Pischke S, Wedemeyer H. Chronic hepatitis E in liver transplant recipients: a significant clinical problem? Minerva Gastroenterol Dietol. 2010 Jun;56(2):121-8.

    PMID: 20485250BACKGROUND

  • 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.

    PMID: 19157619BACKGROUND

  • 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.

    PMID: 19790147BACKGROUND

MeSH Terms

Conditions

Hepatitis E

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Marc G Ghany, M.D.

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2014

First Posted

July 15, 2014

Study Start

July 12, 2014

Primary Completion

February 5, 2019

Study Completion

February 5, 2019

Last Updated

May 4, 2026

Record last verified: 2026-04-30

Locations

US(3)