<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02190253</url>
  </required_header>
  <id_info>
    <org_study_id>999914148</org_study_id>
    <secondary_id>14-DK-N148</secondary_id>
    <nct_id>NCT02190253</nct_id>
  </id_info>
  <brief_title>Seroprevalence of Hepatitis E in People With an Organ Transplant</brief_title>
  <official_title>Seroprevalence of Hepatitis E in The Organ Transplant Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - The hepatitis E virus causes an acute hepatitis that usually goes away by itself.&#xD;
      Researchers in France studied people who received a liver or kidney transplant. They found&#xD;
      that hepatitis E may not go away by itself in these people. It becomes chronic. This can&#xD;
      cause serious liver disease. More than half the people who had organ transplant who had&#xD;
      hepatitis E seemed to get a chronic infection.&#xD;
&#xD;
      Researchers want to find out if hepatitis E happens this often in patients who have liver,&#xD;
      kidney, or small bowel transplants in the United States. If it does, they want to know why.&#xD;
      They want to know if chronic hepatitis E will become an important medical problem. This&#xD;
      research might help improve care for people who have a transplant. It also might help&#xD;
      researchers prevent the spread of hepatitis E.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To see how many patients who have received or are waiting for certain transplants have&#xD;
      antibodies to hepatitis E virus.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults over age 18 who have had a liver, kidney, liver and kidney, or small bowel&#xD;
      transplant, or are on a waiting list for one.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be enrolled from 3 transplant centers.&#xD;
&#xD;
        -  Participants will complete a questionnaire. They will be asked about possible risk&#xD;
           factors for hepatitis E exposure.&#xD;
&#xD;
        -  Participants will have a blood sample drawn through a needle placed in a vein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis E virus infection commonly presents as an acute self-limiting hepatitis in the&#xD;
      developing world. However there have been reports that chronic hepatitis E may develop in&#xD;
      immunocompromised subjects such as renal and liver transplant recipients. Progression to&#xD;
      cirrhosis has also been reported in patients with chronic hepatitis E infection. We&#xD;
      hypothesize that immunosuppression post-organ transplantation predisposes individuals to&#xD;
      increased susceptibility to hepatitis E infection. Therefore, in this study, we wish to&#xD;
      determine the seroprevalence of antibody to hepatitis E IgG in organ transplant recipients&#xD;
      (an immunosuppressed population) and compare it to patients who are on organ transplant&#xD;
      waitlist (not immunosuppressed). We plan to study samples and date from 300 organ transplant&#xD;
      recipients and 300 patients on waitlist for liver, kidney or intestinal transplantation and&#xD;
      control for age, gender, organ and transplant center. Three transplant centers (2 in the&#xD;
      mid-Atlantic area and one in the Mid-West) will each enroll 100 cases and controls. A minimum&#xD;
      of 50 cases at each site will be liver transplant recipients. Cases will be stratified based&#xD;
      on number of years post transplant one, two or greater than or equal to three years.&#xD;
      Consecutive patients who are eligible and agree to participate in the study will be enrolled.&#xD;
      A brief questionnaire to assess risk factors for acquisition of hepatitis E will be&#xD;
      administered and 8mls of blood will be drawn in a serum separator tube for anti HEV IgG, anti&#xD;
      HEV IgM and HEV RNA testing analysis at the NIH. Subjects who are confirmed to have acute or&#xD;
      chronic HEV infection will be managed according to standard of care at each respective&#xD;
      transplant centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2014</start_date>
  <completion_date type="Actual">February 5, 2019</completion_date>
  <primary_completion_date type="Actual">February 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Seroprevalence of anti-HEV</measure>
    <time_frame>Baseline</time_frame>
    <description>Seroprevalence of antibody to hepatitis E IgG</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">447</enrollment>
  <condition>Hepatitis E</condition>
  <arm_group>
    <arm_group_label>Organ transplant recipients</arm_group_label>
    <description>Recipients of either liver, kidney, liver and kidney, and small bowel transplants</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist patients</arm_group_label>
    <description>Patients on waitlist for liver, kidney or intestinal transplantation</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Tertiary referral center with liver transplant program&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  ELIGIBILITY CRITERIA:&#xD;
&#xD;
        Inclusion criteria for post-transplant subjects&#xD;
&#xD;
          -  Age greater than or equal to 18 years, male or female&#xD;
&#xD;
          -  Recipients of either liver, kidney, liver and kidney, and small bowel transplants&#xD;
&#xD;
          -  Survival for a minimum of 1 year post-transplant&#xD;
&#xD;
          -  Willingness to provide written, informed consent&#xD;
&#xD;
        Exclusion criteria for post-transplant subjects:&#xD;
&#xD;
          -  Current or previous treatment within the last year with peg-interferon and or&#xD;
             ribavirin.&#xD;
&#xD;
          -  Known history of hepatitis E infection.&#xD;
&#xD;
        Inclusion criteria for waitlist subjects:&#xD;
&#xD;
          -  Age greater than or equal to 18 years, male or female&#xD;
&#xD;
          -  Subjects on the waitlist for first liver, kidney, liver and kidney or small bowel&#xD;
             transplant&#xD;
&#xD;
          -  Willingness to provide written, informed consent&#xD;
&#xD;
        Exclusion criteria for waitlist subjects:&#xD;
&#xD;
          -  Current or previous treatment within the last year with peg-interferon and or&#xD;
             ribavirin.&#xD;
&#xD;
          -  Current immunosuppression&#xD;
&#xD;
          -  Known history of hepatitis E infection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc G Ghany, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgetown University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007-2197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-6056</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pischke S, Wedemeyer H. Chronic hepatitis E in liver transplant recipients: a significant clinical problem? Minerva Gastroenterol Dietol. 2010 Jun;56(2):121-8.</citation>
    <PMID>20485250</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19157619</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19790147</PMID>
  </reference>
  <verification_date>June 30, 2023</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 11, 2023</last_update_submitted>
  <last_update_submitted_qc>July 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Renal Threshold</keyword>
  <keyword>Liver Transplant</keyword>
  <keyword>Transplantation</keyword>
  <keyword>Hepatitis E</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis E</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02190253
org study id: 999914148
secondary id: 14-DK-N148
nct id: NCT02190253
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
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
measure: Seroprevalence of anti-HEV
time frame: Baseline
description: Seroprevalence of antibody to hepatitis E IgG
arm group label: Organ transplant recipients
description: Recipients of either liver, kidney, liver and kidney, and small bowel transplants
arm group label: Waitlist patients
description: Patients on waitlist for liver, kidney or intestinal transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Marc G Ghany, M.D.
role: Principal Investigator
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
facility: 
facility: 
facility: 
country: United States
citation: 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: 20485250
citation: 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: 19157619
citation: 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: 19790147
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis E
mesh term: Hepatitis