<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/NCT03781726</url>
  </required_header>
  <id_info>
    <org_study_id>2018P003140</org_study_id>
    <nct_id>NCT03781726</nct_id>
  </id_info>
  <brief_title>Multi-center Study to Transplant Hepatitis-C Infected Kidneys</brief_title>
  <acronym>MYTHIC</acronym>
  <official_title>A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Raymond Chung</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</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>
      Open label multi center study for the donation of HCV positive kidneys to HCV negative&#xD;
      recipients with interventional treatment to prevent HCV transmission upon transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objective is to determine if the administration of the direct acting antiviral&#xD;
      glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective&#xD;
      at preventing the spread of HCV infection from donor kidney with known HCV infection (all&#xD;
      genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks&#xD;
      post treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">March 20, 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>Number of Participants With Undetectable HCV</measure>
    <time_frame>12 weeks post treatment</time_frame>
    <description>HCV RNA &lt; LLOQ 12 weeks after the last actual dose of G/P</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With On-treatment Virologic Failure</measure>
    <time_frame>During 8 week treatment course</time_frame>
    <description>HCV RNA &gt; LLOQ during G/P treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With Post-treatment Virologic Relapse</measure>
    <time_frame>During 12 week post treatment follow-up</time_frame>
    <description>HCV RNA &gt; LLOQ after completion of G/P treatment and prior HCV RNA &lt; LLOQ while on treatment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Renal Failure Chronic</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Treatment with glecaprevir/pibrentasvir Fixed Dose Combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>glecaprevir/pibrentasvir treatment</intervention_name>
    <description>combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
    <arm_group_label>Treatment with glecaprevir/pibrentasvir Fixed Dose Combination</arm_group_label>
    <other_name>Mavyret treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Recipient Inclusion Criteria:&#xD;
&#xD;
          -  Estimated glomerular filtration rate(eGFR) &lt; 15 ml/min/1.73 m2&#xD;
&#xD;
          -  Listed for an isolated kidney transplantation&#xD;
&#xD;
          -  Able to understand and adhere to the study visit schedule and all other protocol&#xD;
             requirements, and must voluntarily sign and date an informed consent&#xD;
&#xD;
          -  No available medically acceptable, compatible living kidney donor&#xD;
&#xD;
          -  Subject must agree to use an effective method of birth control per protocol&#xD;
             specifications&#xD;
&#xD;
        Recipient Exclusion Criteria:&#xD;
&#xD;
          -  History of severe, life-threatening or other significant sensitivity to&#xD;
             immunosuppressants utilized in kidney transplant&#xD;
&#xD;
          -  Female who is pregnant, breastfeeding, or is planning to become pregnant during the&#xD;
             course of the study&#xD;
&#xD;
          -  History of HIV&#xD;
&#xD;
          -  HCV RNA positive&#xD;
&#xD;
          -  HBV surface Ag-positive or detectable HBV DNA&#xD;
&#xD;
          -  Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased&#xD;
             risk of causing early graft failure as assessed by the transplant nephrologist and/or&#xD;
             investigator team&#xD;
&#xD;
          -  Presence of clinically significant liver disease&#xD;
&#xD;
          -  Transplant candidate requiring antibody desensitization protocol for transplantation&#xD;
&#xD;
          -  Most recent calculated panel reactive antibody (cPRA) &gt;80%.&#xD;
&#xD;
          -  Prior recipient of a non-renal solid organ transplant&#xD;
&#xD;
        Donor Organ Inclusion Criteria&#xD;
&#xD;
          -  Deceased donor organ with kidney donor profile index (KDPI) ≤0.85&#xD;
&#xD;
          -  HCV RNA-positive&#xD;
&#xD;
        Donor Organ Exclusion Criteria&#xD;
&#xD;
          -  Known prior HCV treatment with direct acting antiviral medication&#xD;
&#xD;
          -  HIV RNA-positive&#xD;
&#xD;
          -  HBV Surface antigen-positive or HBV DNA-positive&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</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>Northwestern Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <results_first_submitted>April 9, 2021</results_first_submitted>
  <results_first_submitted_qc>May 7, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 11, 2021</results_first_posted>
  <last_update_submitted>January 18, 2022</last_update_submitted>
  <last_update_submitted_qc>January 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Raymond Chung</investigator_full_name>
    <investigator_title>Director of Hepatology</investigator_title>
  </responsible_party>
  <keyword>hemodialysis</keyword>
  <keyword>renal failure</keyword>
  <keyword>kidney transplant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Coded data is anticipated to be shared with collaborators in this multi-center consortium</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Real time</ipd_time_frame>
    <ipd_access_criteria>researchers accessing IPD must be an approved site within the consortium.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 13, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03781726/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 26, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT03781726/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
          <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
          <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57" lower_limit="51" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kidney disease etiology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Diabetic nephropathy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hypertension</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Polycystic kidney disease</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Congenital/genetic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IgA nephropathy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>On dialysis at baseline</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from consent to transplant</title>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.29" lower_limit="1.86" upper_limit="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time spent on waitlist at time of consent</title>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137" lower_limit="95" upper_limit="219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <population>One patient missing BMI data</population>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.5" lower_limit="25.7" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Undetectable HCV</title>
        <description>HCV RNA &lt; LLOQ 12 weeks after the last actual dose of G/P</description>
        <time_frame>12 weeks post treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
            <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Undetectable HCV</title>
          <description>HCV RNA &lt; LLOQ 12 weeks after the last actual dose of G/P</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With On-treatment Virologic Failure</title>
        <description>HCV RNA &gt; LLOQ during G/P treatment</description>
        <time_frame>During 8 week treatment course</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
            <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With On-treatment Virologic Failure</title>
          <description>HCV RNA &gt; LLOQ during G/P treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With Post-treatment Virologic Relapse</title>
        <description>HCV RNA &gt; LLOQ after completion of G/P treatment and prior HCV RNA &lt; LLOQ while on treatment</description>
        <time_frame>During 12 week post treatment follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
            <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With Post-treatment Virologic Relapse</title>
          <description>HCV RNA &gt; LLOQ after completion of G/P treatment and prior HCV RNA &lt; LLOQ while on treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline (day of transplant) to one year post transplant (1 year total)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)</title>
          <description>8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir&#xD;
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>neutrophil count decreased</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>febrile neutropenia</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hemorrhoidal hemorrhage</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>heart failure</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>chest pain</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>vomiting</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>gastritis</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>small intestinal obstruction</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>ileus</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>abdominal infection</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>acute cellular rejection</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>coronavirus infection</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>fever</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>cytomegalovirus infection reactivation</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>sepsis</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>postoperative hemorrhage</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>drug toxicity due to accidental overdosage</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>stroke</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>acute kidney injury</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>renal calculi</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>post procedural urine leak</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>renal graft function delayed</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>dysuria</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>urinary tract obstruction</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>hypotension</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>syncope</sub_title>
                <description>not related to study drug/procedure</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>neutrophil count decreased</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>platelet count decreased</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>white blood cell count decreased</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>hyperglycemia</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>abdominal pain</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>constipation</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>gastritis</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>gastroesophageal reflux disease</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>vomiting</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>chills</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>fatigue</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>nausea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>acute cellular rejection</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>cytomegalovirus infection reactivation</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>pain in extremity</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>dizziness</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>headache</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>tremor</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>anxiety</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>acute kidney injury</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>bladder spasm</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>creatinine increased</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hyperkalemia</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>renal graft function delayed</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>urinary retention</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>urinary tract infection</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>dyspnea</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>nasal congestion</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>edema limbs</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hypertension</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>hypotension</sub_title>
                <description>not related to study drug/procedures</description>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Peter Reese</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-573-8070</phone>
      <email>Peter.Reese@pennmedicine.upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03781726
org study id: 2018P003140
nct id: NCT03781726
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Open label multi center study for the donation of HCV positive kidneys to HCV negative
      recipients with interventional treatment to prevent HCV transmission upon transplantation.
The study objective is to determine if the administration of the direct acting antiviral
      glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective
      at preventing the spread of HCV infection from donor kidney with known HCV infection (all
      genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks
      post treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Undetectable HCV
time frame: 12 weeks post treatment
description: HCV RNA < LLOQ 12 weeks after the last actual dose of G/P
measure: Percentage of Subjects With On-treatment Virologic Failure
time frame: During 8 week treatment course
description: HCV RNA > LLOQ during G/P treatment
measure: Percentage of Subjects With Post-treatment Virologic Relapse
time frame: During 12 week post treatment follow-up
description: HCV RNA > LLOQ after completion of G/P treatment and prior HCV RNA < LLOQ while on treatment
arm group label: Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
arm group type: Experimental
description: 8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
intervention type: Drug
intervention name: glecaprevir/pibrentasvir treatment
description: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
arm group label: Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
other name: Mavyret treatment
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Raymond T Chung, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Raymond Chung
investigator title: Director of Hepatology
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
sharing ipd: Yes
ipd description: Coded data is anticipated to be shared with collaborators in this multi-center consortium
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Real time
ipd access criteria: researchers accessing IPD must be an approved site within the consortium.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 