<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/NCT02243280</url>
  </required_header>
  <id_info>
    <org_study_id>M14-867</org_study_id>
    <secondary_id>2014-002925-36</secondary_id>
    <nct_id>NCT02243280</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection</brief_title>
  <official_title>An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-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>
      The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the&#xD;
      efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and&#xD;
      without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1&#xD;
      (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated&#xD;
      cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially&#xD;
      planned in the protocol, it was not administered in any of the study arms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consisted of two independent parts: Part 1 was conducted first followed by Part 2.&#xD;
      Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled&#xD;
      participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed&#xD;
      or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV&#xD;
      RNA to evaluate efficacy and the emergence and persistence of viral variants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel 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 (SVR) 12 Weeks Post-treatment</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>The percentage of participants with sustained virologic response (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 Sustained Virologic Response (SVR) 4 Weeks Post-treatment</measure>
    <time_frame>4 weeks after the last actual dose of study drug</time_frame>
    <description>The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Failure</measure>
    <time_frame>Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment</time_frame>
    <description>The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment), confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Post-treatment Relapse</measure>
    <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
    <description>Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>Hepatitis C Virus</condition>
  <condition>HCV</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm K</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-493</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_label>Arm K</arm_group_label>
    <other_name>glecaprevir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-530</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_label>Arm E</arm_group_label>
    <arm_group_label>Arm F</arm_group_label>
    <arm_group_label>Arm G</arm_group_label>
    <arm_group_label>Arm H</arm_group_label>
    <arm_group_label>Arm I</arm_group_label>
    <arm_group_label>Arm J</arm_group_label>
    <arm_group_label>Arm K</arm_group_label>
    <other_name>pibrentasvir</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between 18 and 70 years of age, inclusive, at time of screening&#xD;
&#xD;
          2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and&#xD;
             2) or GT4, GT5, or GT6 (Study Part 2) infection&#xD;
&#xD;
          3. Chronic HCV infection defined as one of the following:&#xD;
&#xD;
               -  Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before&#xD;
                  screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or&#xD;
&#xD;
               -  Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy&#xD;
                  consistent with chronic HCV infection (or a liver biopsy performed prior to&#xD;
                  enrollment with evidence of chronic HCV infection)&#xD;
&#xD;
          4. Participant had to meet one of the following criteria:&#xD;
&#xD;
               -  Treatment-naïve: participant had never received treatment for HCV infection&#xD;
&#xD;
               -  Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin&#xD;
                  (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or&#xD;
                  prior relapse) (for Study Part 2)&#xD;
&#xD;
          5. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study&#xD;
             Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only),&#xD;
             per local standard&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of severe, life-threatening or other significant sensitivity to any drug&#xD;
&#xD;
          2. Female who is pregnant, planning to become pregnant during the study or breastfeeding;&#xD;
             or male whose partner is pregnant or planning to become pregnant during the study&#xD;
&#xD;
          3. Recent (within 6 months prior to study drug administration) history of drug or alcohol&#xD;
             abuse that could preclude adherence to the protocol in the opinion of the investigator&#xD;
&#xD;
          4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or&#xD;
             anti-human immunodeficiency virus antibody (HIV Ab)&#xD;
&#xD;
          5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection&#xD;
             with more than one HCV genotype&#xD;
&#xD;
          6. Any cause of liver disease other than chronic HCV infection&#xD;
&#xD;
          7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or&#xD;
             unquantifiable or undetectable HCV RNA at screening&#xD;
&#xD;
          8. Previous use of an HCV direct-acting antiviral agent (DAA)&#xD;
&#xD;
          9. Consideration by the investigator, for any reason, that the participant was an&#xD;
             unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects&#xD;
             only)&#xD;
&#xD;
         10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past&#xD;
             clinical evidence of Child-Pugh B or C Classification (score of &gt; 6) or clinical&#xD;
             history of liver decompensation, including ascites (noted on physical exam), bleeding&#xD;
             varices, use of beta-blockers for portal hypertension or ascites, or hepatic&#xD;
             encephalopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Armen Asatryan, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.</citation>
    <PMID>27456384</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>February 18, 2017</results_first_submitted>
  <results_first_submitted_qc>February 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">April 6, 2017</results_first_posted>
  <last_update_submitted>July 9, 2021</last_update_submitted>
  <last_update_submitted_qc>July 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV GT4</keyword>
  <keyword>Hepatitis C virus</keyword>
  <keyword>HCV GT1</keyword>
  <keyword>HCV</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>HCV GT6</keyword>
  <keyword>Hepatitis C Genotype 4 (GT 4)</keyword>
  <keyword>Hepatitis C Genotype 1 (GT1)</keyword>
  <keyword>RBV</keyword>
  <keyword>Cirrhotic</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Interferon (IFN) Free</keyword>
  <keyword>IFN free</keyword>
  <keyword>HCV GT5</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Ribavirin</keyword>
  <keyword>Child Pugh A</keyword>
  <keyword>Hepatitis C Genotype 5 (GT 5)</keyword>
  <keyword>Hepatitis C Genotype 6 (GT 6)</keyword>
  <keyword>ABT-493</keyword>
  <keyword>ABT-530</keyword>
  <keyword>glecaprevir</keyword>
  <keyword>pibrentasvir</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
        </group>
        <group group_id="P2">
          <title>Arm B</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
        </group>
        <group group_id="P3">
          <title>Arm C</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P4">
          <title>Arm D</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P5">
          <title>Arm E</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P6">
          <title>Arm F</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
        </group>
        <group group_id="P7">
          <title>Arm G</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P8">
          <title>Arm H</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P9">
          <title>Arm I</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
        </group>
        <group group_id="P10">
          <title>Arm J</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="P11">
          <title>Arm K</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Enrolled</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="34"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="34"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treated</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42">Two Arm I participants received ABT-493 doses of 200 mg instead of 300 mg and are included in Arm A</participants>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="32">Two Arm I participants received ABT-493 doses of 200 mg instead of 300 mg and are included in Arm A</participants>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Treatment</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="32"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="39"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="27"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="31"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
        </group>
        <group group_id="B2">
          <title>Arm B</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
        </group>
        <group group_id="B3">
          <title>Arm C</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B4">
          <title>Arm D</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B5">
          <title>Arm E</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B6">
          <title>Arm F</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
        </group>
        <group group_id="B7">
          <title>Arm G</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B8">
          <title>Arm H</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B9">
          <title>Arm I</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
        </group>
        <group group_id="B10">
          <title>Arm J</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
        </group>
        <group group_id="B11">
          <title>Arm K</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
        </group>
        <group group_id="B12">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="39"/>
            <count group_id="B3" value="0"/>
            <count group_id="B4" value="0"/>
            <count group_id="B5" value="0"/>
            <count group_id="B6" value="27"/>
            <count group_id="B7" value="0"/>
            <count group_id="B8" value="0"/>
            <count group_id="B9" value="32"/>
            <count group_id="B10" value="0"/>
            <count group_id="B11" value="34"/>
            <count group_id="B12" value="174"/>
          </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="52.4" spread="10.01"/>
                    <measurement group_id="B2" value="52.5" spread="10.41"/>
                    <measurement group_id="B6" value="58.9" spread="5.47"/>
                    <measurement group_id="B9" value="55.0" spread="11.13"/>
                    <measurement group_id="B11" value="53.5" spread="10.34"/>
                    <measurement group_id="B12" value="54.1" spread="9.98"/>
                  </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="17"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="7"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="15"/>
                    <measurement group_id="B12" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="20"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="16"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="19"/>
                    <measurement group_id="B12" value="98"/>
                  </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 (SVR) 12 Weeks Post-treatment</title>
        <description>The percentage of participants with sustained virologic response (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>Intention-to-treat population: all participants who received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O8">
            <title>Arm H</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O9">
            <title>Arm I</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>Arm J</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O11">
            <title>Arm K</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment</title>
          <description>The percentage of participants with sustained virologic response (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>Intention-to-treat population: all participants who received at least 1 dose of study drug</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="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="91.2" upper_limit="100"/>
                    <measurement group_id="O2" value="97.4" lower_limit="86.8" upper_limit="99.5"/>
                    <measurement group_id="O6" value="96.3" lower_limit="81.7" upper_limit="99.3"/>
                    <measurement group_id="O9" value="100" lower_limit="89.8" upper_limit="100"/>
                    <measurement group_id="O11" value="97.1" lower_limit="85.1" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment</title>
        <description>The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
        <time_frame>4 weeks after the last actual dose of study drug</time_frame>
        <population>Intention-to-treat population: all participants who received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O8">
            <title>Arm H</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O9">
            <title>Arm I</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>Arm J</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O11">
            <title>Arm K</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment</title>
          <description>The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [&lt;LLOQ]) 4 weeks after the last dose of study drug.</description>
          <population>Intention-to-treat population: all participants who received at least 1 dose of study drug</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="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="91.2" upper_limit="100"/>
                    <measurement group_id="O2" value="97.4" lower_limit="86.8" upper_limit="99.5"/>
                    <measurement group_id="O6" value="96.3" lower_limit="81.7" upper_limit="99.3"/>
                    <measurement group_id="O9" value="100" lower_limit="89.8" upper_limit="100"/>
                    <measurement group_id="O11" value="100" lower_limit="89.8" upper_limit="100"/>
                  </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>The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment), confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
        <time_frame>Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment</time_frame>
        <population>Intention-to-treat population: all participants who received at least 1 dose of study drug</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O8">
            <title>Arm H</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O9">
            <title>Arm I</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>Arm J</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O11">
            <title>Arm K</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Failure</title>
          <description>The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment), confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.</description>
          <population>Intention-to-treat population: all participants who received at least 1 dose of study drug</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="40"/>
                <count group_id="O2" value="39"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="34"/>
              </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="8.8"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="9.0"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="12.5"/>
                    <measurement group_id="O9" value="0" lower_limit="0.0" upper_limit="10.2"/>
                    <measurement group_id="O11" value="0" lower_limit="0.0" upper_limit="10.2"/>
                  </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 hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
        <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O4">
            <title>Arm D</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O5">
            <title>Arm E</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O6">
            <title>Arm F</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis</description>
          </group>
          <group group_id="O7">
            <title>Arm G</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O8">
            <title>Arm H</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O9">
            <title>Arm I</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis</description>
          </group>
          <group group_id="O10">
            <title>Arm J</title>
            <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)</description>
          </group>
          <group group_id="O11">
            <title>Arm K</title>
            <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Post-treatment Relapse</title>
          <description>Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
          <population>All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit</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="40"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="27"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="34"/>
                <count group_id="O10" value="0"/>
                <count group_id="O11" value="33"/>
              </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="8.8"/>
                    <measurement group_id="O2" value="2.6" lower_limit="0.5" upper_limit="13.5"/>
                    <measurement group_id="O6" value="3.7" lower_limit="0.7" upper_limit="18.3"/>
                    <measurement group_id="O9" value="0" lower_limit="0.0" upper_limit="10.2"/>
                    <measurement group_id="O11" value="0" lower_limit="0.0" upper_limit="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm A</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
        </group>
        <group group_id="E2">
          <title>Arm B</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis</description>
        </group>
        <group group_id="E3">
          <title>Arm F</title>
          <description>ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis</description>
        </group>
        <group group_id="E4">
          <title>Arm I</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis</description>
        </group>
        <group group_id="E5">
          <title>Arm K</title>
          <description>ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</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="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER METASTATIC</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>PULMONARY EMBOLISM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</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="22" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="19" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VISION BLURRED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>FLATULENCE</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>MUSCLE STRAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </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="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>MEMORY IMPAIRMENT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PARANASAL SINUS DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERHIDROSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="39"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="34"/>
              </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/NCT02243280
org study id: M14-867
secondary id: 2014-002925-36
nct id: NCT02243280
lead sponsor: 
has dmc: No
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the
      efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and
      without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1
      (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated
      cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially
      planned in the protocol, it was not administered in any of the study arms.
This study consisted of two independent parts: Part 1 was conducted first followed by Part 2.
      Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled
      participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed
      or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV
      RNA to evaluate efficacy and the emergence and persistence of viral variants.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
time frame: 12 weeks after the last actual dose of study drug
description: The percentage of participants with sustained virologic response (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 Sustained Virologic Response (SVR) 4 Weeks Post-treatment
time frame: 4 weeks after the last actual dose of study drug
description: The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
measure: Percentage of Participants With On-treatment Virologic Failure
time frame: Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment
description: The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
measure: Percentage of Participants With Post-treatment Relapse
time frame: From the end of treatment through 12 weeks after the last dose of study drug
description: Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
arm group label: Arm A
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
arm group label: Arm B
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
arm group label: Arm C
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
arm group label: Arm D
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)
arm group label: Arm E
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
arm group label: Arm F
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
arm group label: Arm G
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
arm group label: Arm H
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)
arm group label: Arm I
arm group type: Experimental
description: ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
arm group label: Arm J
arm group type: Experimental
description: ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)
arm group label: Arm K
arm group type: Experimental
description: ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
intervention type: Drug
intervention name: ABT-493
description: Tablet
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
arm group label: Arm E
arm group label: Arm F
arm group label: Arm G
arm group label: Arm H
arm group label: Arm I
arm group label: Arm J
arm group label: Arm K
other name: glecaprevir
intervention type: Drug
intervention name: ABT-530
description: Tablet
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
arm group label: Arm E
arm group label: Arm F
arm group label: Arm G
arm group label: Arm H
arm group label: Arm I
arm group label: Arm J
arm group label: Arm K
other name: pibrentasvir
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Armen Asatryan, MD
role: Study Director
affiliation: AbbVie
country: Australia
country: Canada
country: France
country: Germany
country: Italy
country: New Zealand
country: Puerto Rico
country: Spain
country: United Kingdom
country: United States
citation: Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, Wyles DL, Hassanein T, Aguilar H, Maliakkal B, Liu R, Lin CW, Ng TI, Kort J, Mensa FJ. High Efficacy of ABT-493 and ABT-530 Treatment in Patients With HCV Genotype 1 or 3 Infection and Compensated Cirrhosis. Gastroenterology. 2016 Oct;151(4):651-659.e1. doi: 10.1053/j.gastro.2016.07.020. Epub 2016 Jul 25.
PMID: 27456384
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 