<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/NCT01704755</url>
  </required_header>
  <id_info>
    <org_study_id>M13-099</org_study_id>
    <secondary_id>2012-003088-23</secondary_id>
    <nct_id>NCT01704755</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis</brief_title>
  <acronym>TURQUOISE-II</acronym>
  <official_title>A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie (prior sponsor, Abbott)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267&#xD;
      (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and&#xD;
      ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus&#xD;
      (HCV) genotype 1-infected adults with compensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the treatment period of the study, participants received treatment with&#xD;
      ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon&#xD;
      completing the treatment period or premature discontinuation of the treatment period,&#xD;
      participants entered a 48-week post-treatment period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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 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 quantitation [&lt; LLOQ]) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (&lt; LLOQ) 12 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period</measure>
    <time_frame>Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</time_frame>
    <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Relapse After Treatment</measure>
    <time_frame>within 12 weeks after the last dose of study drug</time_frame>
    <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA &lt; LLOQ at the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">381</enrollment>
  <condition>Chronic Hepatitis C Infection</condition>
  <condition>Compensated Cirrhosis</condition>
  <arm_group>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-450/r/ABT-267, ABT-333</intervention_name>
    <description>Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet</description>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks</arm_group_label>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks</arm_group_label>
    <other_name>Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>Capsule</description>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks</arm_group_label>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females must be practicing specific forms of birth control on study treatment, or be&#xD;
             post-menopausal for more than 2 years or surgically sterile&#xD;
&#xD;
          -  Male or female between 18 and 70 years, inclusive, at time of Screening.&#xD;
&#xD;
          -  Chronic HCV-infection prior to study enrollment.&#xD;
&#xD;
          -  Screening laboratory result indicating HCV genotype 1-infection.&#xD;
&#xD;
          -  Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at&#xD;
             Screening&#xD;
&#xD;
          -  Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant liver disease with any cause other than HCV as the primary cause&#xD;
&#xD;
          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human&#xD;
             Immunodeficiency virus antibody (HIV Ab) at screening.&#xD;
&#xD;
          -  Prior therapy with direct acting antiviral agents for the treatment of HCV, including&#xD;
             telaprevir and boceprevir.&#xD;
&#xD;
          -  Any current or past clinical evidence of Child-Pugh B or C Classification or clinical&#xD;
             history of liver decompensation including ascites (noted on physical exam), variceal&#xD;
             bleeding or hepatic encephalopathy.&#xD;
&#xD;
          -  A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a&#xD;
             subsequent CT Scan or MRI during the screening period.&#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>Roger Trinh, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Puerto Rico</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.</citation>
    <PMID>24725237</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>December 23, 2014</results_first_submitted>
  <results_first_submitted_qc>December 23, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 6, 2015</results_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cirrhosis</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Child Pugh A</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Hepatitis C Genotype 1</keyword>
  <keyword>Cirrhotic</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>ombitasvir</keyword>
  <keyword>paritaprevir</keyword>
  <keyword>dasabuvir</keyword>
  <keyword>Interferon-Free</keyword>
  <keyword>Viekira Pak</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <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>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>In the 12-week treatment group, one participant withdrew from the study before receiving study drug.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 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="208"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="204"/>
                <participants group_id="P2" count="163"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="196"/>
                <participants group_id="P2" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (not specified)</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew consent and personal issues</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
        </group>
        <group group_id="B3">
          <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="208"/>
            <count group_id="B2" value="172"/>
            <count group_id="B3" value="380"/>
          </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="57.1" spread="7.01"/>
                    <measurement group_id="B2" value="56.5" spread="7.87"/>
                    <measurement group_id="B3" value="56.8" spread="7.41"/>
                  </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="62"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="121"/>
                    <measurement group_id="B3" value="267"/>
                  </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 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 quantitation [&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 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 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 quantitation [&lt; LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All randomized participants who received at least 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8"/>
                    <measurement group_id="O2" value="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>91.8</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>87.6</ci_lower_limit>
            <ci_upper_limit>96.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>91.8</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>87.6</ci_lower_limit>
            <ci_upper_limit>96.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>96.5</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.4</ci_lower_limit>
            <ci_upper_limit>99.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>96.5</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.4</ci_lower_limit>
            <ci_upper_limit>99.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm</title>
        <description>A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) 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 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm</title>
          <description>A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) 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 1 dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8"/>
                    <measurement group_id="O2" value="96.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>0.051</p_value>
            <method>Regression, Logistic</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period</title>
        <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
        <time_frame>Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24</time_frame>
        <population>All randomized participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period</title>
          <description>Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA &lt; LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
          <population>All randomized 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="208"/>
                <count group_id="O2" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.0" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.0" upper_limit="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Relapse After Treatment</title>
        <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment 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 1 dose of study drug with HCV RNA &lt; LLOQ at the final treatment visit who completed treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
            <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Relapse After Treatment</title>
          <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA &lt; LLOQ at the end of treatment.</description>
          <population>All randomized participants who received at least 1 dose of study drug with HCV RNA &lt; LLOQ at the final treatment visit who 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="203"/>
                <count group_id="O2" value="164"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="2.7" upper_limit="9.2"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.0" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group.</time_frame>
      <desc>Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).</desc>
      <group_list>
        <group group_id="E1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks</title>
          <description>ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if &lt;75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.0</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="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="172"/>
              </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="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>HAEMATEMESIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>MELAENA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>OESOPHAGEAL VARICES HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>MULTI-ORGAN FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>HEPATITIS ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CANDIDIASIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>ENTEROCOCCAL BACTERAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>ESCHERICHIA SEPSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>PHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>CLAVICLE FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>EXTRADURAL HAEMATOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>FEMORAL NECK FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>HEAD INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>TOXICITY TO VARIOUS AGENTS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>WOUND</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD GLUCOSE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>LACTIC ACIDOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>RHABDOMYOLYSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>HEPATOCELLULAR CARCINOMA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>INTRACRANIAL ANEURYSM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>MAJOR DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>CHRONIC OBSTRUCTIVE PULMONARY DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.0</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="175" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="146" subjects_at_risk="172"/>
              </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="15" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL DISTENSION</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>GASTROOESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERBILIRUBINAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="172"/>
              </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="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="172"/>
              </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="10" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>MUSCLE SPASMS</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>MEMORY IMPAIRMENT</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="172"/>
              </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="24" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>PRURITUS GENERALISED</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="172"/>
              </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 Information</name_or_title>
      <organization>AbbVie (prior sponsor, Abbott)</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/NCT01704755
org study id: M13-099
secondary id: 2012-003088-23
nct id: NCT01704755
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267
      (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and
      ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus
      (HCV) genotype 1-infected adults with compensated cirrhosis.
During the treatment period of the study, participants received treatment with
      ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon
      completing the treatment period or premature discontinuation of the treatment period,
      participants entered a 48-week post-treatment period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 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 quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm
time frame: 12 weeks after the last actual dose of study drug
description: A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
measure: Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period
time frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
description: Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
measure: Percentage of Participants With Virologic Relapse After Treatment
time frame: within 12 weeks after the last dose of study drug
description: Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
arm group type: Experimental
description: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
arm group type: Experimental
description: ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
intervention type: Drug
intervention name: ABT-450/r/ABT-267, ABT-333
description: Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
other name: Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir
intervention type: Drug
intervention name: Ribavirin (RBV)
description: Capsule
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Roger Trinh, MD
role: Study Director
affiliation: AbbVie
country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Puerto Rico
country: Spain
country: United Kingdom
country: United States
url: http://rxabbvie.com
description: Related Info
citation: Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.
PMID: 24725237
responsible party type: Sponsor
mesh term: Infections
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: Fibrosis
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 