deltatrials
Completed OBSERVATIONAL NCT02190253

Seroprevalence of Hepatitis E in People With an Organ Transplant

Seroprevalence of Hepatitis E in The Organ Transplant Subjects

Sponsor: Georgetown University

Conditions Hepatitis E
Updated 40 times since 2017 Last updated: Apr 11, 2026 Started: Jul 12, 2014 Primary completion: Feb 5, 2019 Completion: Feb 5, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Hepatitis E, this trial is completed. The trial is conducted by Georgetown University and has accumulated 40 data snapshots since 2014. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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...

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.

Status Flow

~Jan 2017 – ~Jun 2017 · 5 months · monthly snapshot~Jun 2017 – ~Jan 2018 · 7 months · monthly snapshot~Jan 2018 – ~Apr 2018 · 3 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Feb 2019 · 5 months · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Sep 2019 · 6 months · monthly snapshot~Sep 2019 – ~Apr 2020 · 7 months · monthly snapshot~Apr 2020 – ~Jan 2021 · 9 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Oct 2021 · 5 months · monthly snapshot~Oct 2021 – ~Dec 2021 · 2 months · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Apr 2023 · 59 days · monthly snapshot~Apr 2023 – ~Aug 2023 · 4 months · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jul 2024 · 8 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Jun 2025 · 8 months · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Aug 2025 · 31 days · monthly snapshot~Aug 2025 – ~Sep 2025 · 31 days · monthly snapshot~Sep 2025 – ~Oct 2025 · 30 days · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – ~Apr 2026 · 4 months · monthly snapshotApr 16, 2026 – present · 5 months · daily API

Change History

40 versions recorded
  1. Apr 16, 2026 — Present [daily]

    Completed

  2. Dec 2025 — Apr 2026 [monthly]

    Completed

  3. Oct 2025 — Dec 2025 [monthly]

    Completed

  4. Sep 2025 — Oct 2025 [monthly]

    Completed

  5. Aug 2025 — Sep 2025 [monthly]

    Completed

Show 35 earlier versions
  1. Jul 2025 — Aug 2025 [monthly]

    Completed

  2. Jun 2025 — Jul 2025 [monthly]

    Completed

  3. Oct 2024 — Jun 2025 [monthly]

    Completed

  4. Sep 2024 — Oct 2024 [monthly]

    Completed

  5. Jul 2024 — Sep 2024 [monthly]

    Completed

  6. Nov 2023 — Jul 2024 [monthly]

    Completed

  7. Oct 2023 — Nov 2023 [monthly]

    Completed

  8. Aug 2023 — Oct 2023 [monthly]

    Completed

  9. Apr 2023 — Aug 2023 [monthly]

    Completed

  10. Feb 2023 — Apr 2023 [monthly]

    Completed

  11. Dec 2022 — Feb 2023 [monthly]

    Completed

  12. Nov 2022 — Dec 2022 [monthly]

    Completed

  13. Sep 2022 — Nov 2022 [monthly]

    Completed

  14. Jul 2022 — Sep 2022 [monthly]

    Completed

  15. Jun 2022 — Jul 2022 [monthly]

    Completed

  16. May 2022 — Jun 2022 [monthly]

    Completed

  17. Apr 2022 — May 2022 [monthly]

    Completed

  18. Jan 2022 — Apr 2022 [monthly]

    Completed

  19. Dec 2021 — Jan 2022 [monthly]

    Completed

  20. Oct 2021 — Dec 2021 [monthly]

    Completed

  21. May 2021 — Oct 2021 [monthly]

    Completed

  22. Apr 2021 — May 2021 [monthly]

    Completed

  23. Mar 2021 — Apr 2021 [monthly]

    Completed

  24. Feb 2021 — Mar 2021 [monthly]

    Completed

  25. Jan 2021 — Feb 2021 [monthly]

    Completed

  26. Apr 2020 — Jan 2021 [monthly]

    Completed

  27. Sep 2019 — Apr 2020 [monthly]

    Completed

  28. Mar 2019 — Sep 2019 [monthly]

    Completed

    Status: RecruitingCompleted

  29. Feb 2019 — Mar 2019 [monthly]

    Recruiting

  30. Sep 2018 — Feb 2019 [monthly]

    Recruiting

  31. Jun 2018 — Sep 2018 [monthly]

    Recruiting

  32. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  33. Jan 2018 — Apr 2018 [monthly]

    Recruiting NA

  34. Jun 2017 — Jan 2018 [monthly]

    Recruiting NA

  35. Jan 2017 — Jun 2017 [monthly]

    Recruiting NA

    First recorded

Jul 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility 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.

Contact Information

Sponsor contact:
  • Georgetown University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Pennsylvania
  • University of Wisconsin, Madison
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .