<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/NCT02207088</url>
  </required_header>
  <id_info>
    <org_study_id>M14-226</org_study_id>
    <secondary_id>2014-001527-77</secondary_id>
    <nct_id>NCT02207088</nct_id>
  </id_info>
  <brief_title>Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease</brief_title>
  <official_title>An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week&#xD;
      regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in&#xD;
      HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) &lt;30,&#xD;
      including those on hemodialysis or peritoneal dialysis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2014</start_date>
  <completion_date type="Actual">December 6, 2016</completion_date>
  <primary_completion_date type="Actual">December 6, 2016</primary_completion_date>
  <phase>Phase 3</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>Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Failure</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after &lt; LLOQ during treatment, confirmed increase of &gt; 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Post-Treatment Relapse</measure>
    <time_frame>Within 12 weeks after the last dose of study drug</time_frame>
    <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA &lt; LLOQ at the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>Hepatitis C Virus</condition>
  <condition>Compensated Cirrhosis</condition>
  <condition>Severe Renal Impairment</condition>
  <condition>End-stage Renal Disease</condition>
  <arm_group>
    <arm_group_label>3-DAA (Direct Acting Antivirals) with or without RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ombitasvir/paritaprevir/ritonavir</intervention_name>
    <description>tablet</description>
    <arm_group_label>3-DAA (Direct Acting Antivirals) with or without RBV</arm_group_label>
    <other_name>ABT-450/r/ABT-267</other_name>
    <other_name>Viekira Pak</other_name>
    <other_name>paritaprevir also known as ABT-450</other_name>
    <other_name>ombitasvir also known as ABT-267</other_name>
    <other_name>dasabuvir also known as ABT-333</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dasabuvir</intervention_name>
    <description>tablet</description>
    <arm_group_label>3-DAA (Direct Acting Antivirals) with or without RBV</arm_group_label>
    <other_name>ABT-333</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>tablet</description>
    <arm_group_label>3-DAA (Direct Acting Antivirals) with or without RBV</arm_group_label>
    <other_name>RBV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Positive for anti-HCV Ab (Antibody) and HCV RNA &gt;1,000 IU/mL at Screening.&#xD;
&#xD;
          2. Screening laboratory result indicating HCV genotype 1 infection.&#xD;
&#xD;
          3. Subject has never received antiviral treatment for hepatitis C infection&#xD;
             (treatment-naive subject) or subject has received previous treatment with&#xD;
             peginterferon with or without RBV with non-response (HCV RNA quantifiable at end of&#xD;
             treatment or relapsed after end of treatment).&#xD;
&#xD;
          4. Estimated Glomerular Filtration Rate (eGFR) &lt; 30 mL/min/1.73 m^2 as estimated by the&#xD;
             Modification of Diet in Renal Disease (MDRD) method.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant or breastfeeding.&#xD;
&#xD;
          2. Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human&#xD;
             Immunodeficiency Virus (HIV Ab).&#xD;
&#xD;
          3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical&#xD;
             history of liver decompensation such as ascites (noted on physical exam), variceal&#xD;
             bleeding, or hepatic encephalopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Cohen, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <results_first_submitted>October 13, 2017</results_first_submitted>
  <results_first_submitted_qc>October 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">November 9, 2017</results_first_posted>
  <last_update_submitted>October 13, 2017</last_update_submitted>
  <last_update_submitted_qc>October 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>End-stage renal disease</keyword>
  <keyword>Hepatitis C Genotype 1</keyword>
  <keyword>Severe Renal Impairment</keyword>
  <keyword>renal disease</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Renal impairment</keyword>
  <keyword>dialysis</keyword>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>cirrhosis</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 C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The intent-to-treat (ITT) population consisted of all enrolled participants who received at least 1 dose of study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>3-DAA ± RBV</title>
          <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety and demographic analyses were performed on safety population, which is the same as the ITT population.</population>
      <group_list>
        <group group_id="B1">
          <title>3-DAA ± RBV</title>
          <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="68"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.4" spread="7.00"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All randomized participants who received at least one dose of study drug (ITT population).</population>
        <group_list>
          <group group_id="O1">
            <title>3-DAA ± RBV</title>
            <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
          <population>All randomized participants who received at least one dose of study drug (ITT population).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" lower_limit="85.8" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Virologic Failure</title>
        <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after &lt; LLOQ during treatment, confirmed increase of &gt; 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.</description>
        <time_frame>Up to 24 weeks</time_frame>
        <population>All randomized participants who received at least one dose of study drug (ITT population).</population>
        <group_list>
          <group group_id="O1">
            <title>3-DAA ± RBV</title>
            <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Failure</title>
          <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after &lt; LLOQ during treatment, confirmed increase of &gt; 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.</description>
          <population>All randomized participants who received at least one dose of study drug (ITT population).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Post-Treatment Relapse</title>
        <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA &lt; LLOQ at the end of treatment.</description>
        <time_frame>Within 12 weeks after the last dose of study drug</time_frame>
        <population>All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA &lt; LLOQ at the end of treatment and completed treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>3-DAA ± RBV</title>
            <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Post-Treatment Relapse</title>
          <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA &lt; LLOQ at the end of treatment.</description>
          <population>All randomized participants who received at least one dose of study drug (ITT population) with HCV RNA &lt; LLOQ at the end of treatment and completed treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="65"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.3" upper_limit="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks).</time_frame>
      <desc>TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>3-DAA +/- RBV</title>
          <description>3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDra 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ANGINA PECTORIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>CARDIAC ARREST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>CARDIAC TAMPONADE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>CARDIO-RESPIRATORY ARREST</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>CORONARY ARTERY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>LEFT VENTRICULAR DYSFUNCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>SMALL INTESTINAL OBSTRUCTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>VOLVULUS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>LIVER INJURY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>ARTERIOVENOUS GRAFT SITE INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>INTERVERTEBRAL DISCITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>PERITONITIS BACTERIAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>STAPHYLOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>VASCULAR PSEUDOANEURYSM</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>HYPOGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>LOSS OF CONSCIOUSNESS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>MENTAL STATUS CHANGES</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>PLEURAL EFFUSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>ACCELERATED HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>HYPERTENSIVE CRISIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDra 19.1</default_vocab>
        <default_assessment>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="51" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>HAEMOGLOBIN DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="68"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="68"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="68"/>
              </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>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
    </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/NCT02207088
org study id: M14-226
secondary id: 2014-001527-77
nct id: NCT02207088
lead sponsor: 
has dmc: No
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week
      regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in
      HCV-genotype 1-infected subjects with an Estimated Glomerular Filtration Rate (eGFR) <30,
      including those on hemodialysis or peritoneal dialysis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 (SVR12) Weeks Post-treatment
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With On-treatment Virologic Failure
time frame: Up to 24 weeks
description: On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after < LLOQ during treatment, confirmed increase of > 1 log (subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment, or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks of treatment.
measure: Percentage of Participants With Post-Treatment Relapse
time frame: Within 12 weeks after the last dose of study drug
description: Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after the last dose of study drug among participants completing treatment and with HCV RNA < LLOQ at the end of treatment.
arm group label: 3-DAA (Direct Acting Antivirals) with or without RBV
arm group type: Experimental
description: 3-DAA (ombitasvir/paritaprevir/ritonavir 25 mg/150 mg/100 mg once daily [QD] and dasabuvir 250 mg twice daily [BID]) with or without ribavirin (RBV; dosed divided twice a day) for 12 or 24 weeks
intervention type: Drug
intervention name: ombitasvir/paritaprevir/ritonavir
description: tablet
arm group label: 3-DAA (Direct Acting Antivirals) with or without RBV
other name: ABT-450/r/ABT-267
other name: Viekira Pak
other name: paritaprevir also known as ABT-450
other name: ombitasvir also known as ABT-267
other name: dasabuvir also known as ABT-333
intervention type: Drug
intervention name: dasabuvir
description: tablet
arm group label: 3-DAA (Direct Acting Antivirals) with or without RBV
other name: ABT-333
intervention type: Drug
intervention name: Ribavirin
description: tablet
arm group label: 3-DAA (Direct Acting Antivirals) with or without RBV
other name: RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Eric Cohen, MD
role: Study Director
affiliation: AbbVie
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Liver Cirrhosis
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Renal Insufficiency
mesh term: Fibrosis
mesh term: Ritonavir
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 