<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/NCT03026023</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000074</org_study_id>
    <nct_id>NCT03026023</nct_id>
  </id_info>
  <brief_title>Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant</brief_title>
  <official_title>A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raymond T. Chung, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a proof of concept, single center study for the donation of HCV-positive hearts to&#xD;
      HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks&#xD;
      of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon&#xD;
      transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1 of this study will be a single case study with only one subject enrolled. Once safety&#xD;
      has been demonstrated and HCV infection transmission shown to be prevented by the protocol,&#xD;
      the study will expand to 10 additional patients.&#xD;
&#xD;
      Patients will be selected based on their diminished likelihood of receiving a heart from the&#xD;
      waitlist within a period during which they would be likely to succumb to severe&#xD;
      comorbidities. This will be determined in part through use of a patient's listing status (1A,&#xD;
      1B, 2) and clinical judgment, and the Seattle Heart Failure Model.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    moved forward with another protocol utilizing pan genotypic treatment once it became&#xD;
    commercially available and FDA approved&#xD;
  </why_stopped>
  <start_date type="Anticipated">August 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Undetectable HCV</measure>
    <time_frame>12 Weeks post treatment</time_frame>
    <description>Negative HCV viral RNA at 12 weeks after the last dose of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation</measure>
    <time_frame>Upto 16 Weeks</time_frame>
    <description>Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cardiac Transplant Disorder</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Treatment with grazoprevir + elbasvir +/- ribavirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin</intervention_name>
    <description>HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.</description>
    <arm_group_label>Treatment with grazoprevir + elbasvir +/- ribavirin</arm_group_label>
    <other_name>Zepatier</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Recipient is Age ≥ 18 years&#xD;
&#xD;
          -  Serum ALT within normal limits with no history of liver disease&#xD;
&#xD;
          -  Lack of sensitization (i.e. PRA &lt; 20%) that would be expected to result in a high&#xD;
             likelihood of needing aggressive immunosuppression to treat rejection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sensitization (i.e. PRA &gt;20%)&#xD;
&#xD;
          -  Any liver disease in recipient&#xD;
&#xD;
          -  Albumin &lt; 3g/dl or platelet count &lt; 75 x 103/mL&#xD;
&#xD;
          -  Need for dual organ transplant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond T Chung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Masschusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Raymond T. Chung, MD</investigator_full_name>
    <investigator_title>Director of Hepatology</investigator_title>
  </responsible_party>
  <keyword>Heart Transplant</keyword>
  <keyword>Cardiac Transplant</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Zepatier</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Grazoprevir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified patient data will be shared with research collaborators for safety and data analysis.</ipd_description>
  </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/NCT03026023
org study id: 2017P000074
nct id: NCT03026023
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a proof of concept, single center study for the donation of HCV-positive hearts to
      HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks
      of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon
      transplantation.
Phase 1 of this study will be a single case study with only one subject enrolled. Once safety
      has been demonstrated and HCV infection transmission shown to be prevented by the protocol,
      the study will expand to 10 additional patients.

      Patients will be selected based on their diminished likelihood of receiving a heart from the
      waitlist within a period during which they would be likely to succumb to severe
      comorbidities. This will be determined in part through use of a patient's listing status (1A,
      1B, 2) and clinical judgment, and the Seattle Heart Failure Model.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Undetectable HCV
time frame: 12 Weeks post treatment
description: Negative HCV viral RNA at 12 weeks after the last dose of treatment.
measure: Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation
time frame: Upto 16 Weeks
description: Safety and tolerability of grazoprevir and elbasvir in the cardiac transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.
arm group label: Treatment with grazoprevir + elbasvir +/- ribavirin
arm group type: Experimental
description: 12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin
intervention type: Drug
intervention name: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin
description: HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.
arm group label: Treatment with grazoprevir + elbasvir +/- ribavirin
other name: Zepatier
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond T Chung, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Raymond T. Chung, MD
investigator title: Director of Hepatology
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Grazoprevir
sharing ipd: Yes
ipd description: Deidentified patient data will be shared with research collaborators for safety and data analysis.