<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/NCT04452578</url>
  </required_header>
  <id_info>
    <org_study_id>5190371</org_study_id>
    <nct_id>NCT04452578</nct_id>
  </id_info>
  <brief_title>Hepatitis C Virus (HVC) Positive Heart Grafts in HCV Negative Recipients</brief_title>
  <official_title>Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loma Linda University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loma Linda University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor&#xD;
      grafts in HCV negative heart recipients who are currently listed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">June 17, 2022</completion_date>
  <primary_completion_date type="Actual">June 17, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Survival Rate</measure>
    <time_frame>15 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Experimental: Recipient of HCV positive heart graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure: Heart Transplantation</intervention_name>
    <description>A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.</description>
    <arm_group_label>Experimental: Recipient of HCV positive heart graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Active on the transplant list&#xD;
&#xD;
          -  Donor organ with Antibody and NAT (nucleic acid test) positive for HCV&#xD;
&#xD;
          -  HCV negative recipient; this includes patients who never had HCV and those with HCV&#xD;
             previously eradicated with antiviral therapy. The latter is defined as those with&#xD;
             undetectable HCV viral load at least 3 months since stopping therapy.&#xD;
&#xD;
          -  Willing and able to provide written informed consent or for those subjects where&#xD;
             hepatic encephalopathy affects their ability to provide initial or ongoing consent,&#xD;
             has an appropriate and legally-authorized representative willing and able to provide&#xD;
             consent on behalf of the subject&#xD;
&#xD;
          -  Patients listed for multiple organ transplant (heart and kidney or heart and liver)&#xD;
             can be included based on agreement of non-cardiac organ transplant team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants co-infected with HIV&#xD;
&#xD;
          -  Donor previously treated with an NS5a containing regimen (if treatment history of&#xD;
             donor known)&#xD;
&#xD;
          -  Known allergies or hypersensitivity to DAA or ribavarin&#xD;
&#xD;
          -  Pregnancy and/or actively breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Loma Linda University Transplant Institute</name>
      <address>
        <city>Loma Linda</city>
        <state>California</state>
        <zip>92354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04452578
org study id: 5190371
nct id: NCT04452578
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor
      grafts in HCV negative heart recipients who are currently listed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Survival Rate
time frame: 15 months
arm group label: Experimental: Recipient of HCV positive heart graft
arm group type: Experimental
description: A single center, open-label, pilot study examining 10 adult HCV negative heart transplant subjects who will receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after heart transplantation.
intervention type: Procedure
intervention name: Procedure: Heart Transplantation
description: A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.
arm group label: Experimental: Recipient of HCV positive heart graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No