<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/NCT01716585</url>
  </required_header>
  <id_info>
    <org_study_id>M11-646</org_study_id>
    <secondary_id>2012-002019-25</secondary_id>
    <nct_id>NCT01716585</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Chronic Hepatitis C Infection</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)</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 and&#xD;
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as&#xD;
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected&#xD;
      treatment-naïve adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment</measure>
    <time_frame>12 weeks after the last actual dose of active 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 Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment</measure>
    <time_frame>12 weeks after the last actual dose of active 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment</measure>
    <time_frame>12 weeks after the last actual dose of active 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>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</measure>
    <time_frame>12 weeks after the last actual dose of active study drug</time_frame>
    <description>Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA &lt; LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</measure>
    <time_frame>Within 12 weeks post-treatment</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) greater than or equal to the 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">636</enrollment>
  <condition>Chronic Hepatitis C Infection</condition>
  <arm_group>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABT-450/r/ABT-267, ABT-333</intervention_name>
    <description>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</arm_group_label>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
    <other_name>ABT-267 also known as ombitasvir</other_name>
    <other_name>ABT-450 also known as paritaprevir</other_name>
    <other_name>ABT-333 also known as dasabuvir</other_name>
    <other_name>Viekira PAK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <description>Capsule (double-blind treatment period), tablet (open-label treatment period)</description>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for ABT-450/r/ABT-267</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for ABT-333</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for ribavirin</intervention_name>
    <description>Capsule</description>
    <arm_group_label>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females must be post-menopausal for at least 2 years or surgically sterile or&#xD;
             practicing specific forms of birth control&#xD;
&#xD;
          -  Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL&#xD;
             at screening&#xD;
&#xD;
          -  Subject has never received antiviral treatment for hepatitis C infection&#xD;
&#xD;
          -  No evidence of liver cirrhosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive screen for drugs or alcohol&#xD;
&#xD;
          -  Significant sensitivity to any drug&#xD;
&#xD;
          -  Use of contraindicated medications within 2 weeks of dosing&#xD;
&#xD;
          -  Certain predefined abnormal laboratory tests&#xD;
&#xD;
          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody&#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>Nancy Shulman, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.</citation>
    <PMID>24720703</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 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>Hepatitis C Virus</keyword>
  <keyword>Hepatitis C Genotype 1</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Treatment-Naïve</keyword>
  <keyword>Interferon-Free</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Viekira Pak</keyword>
  <keyword>ombitasvir</keyword>
  <keyword>paritaprevir</keyword>
  <keyword>dasabuvir</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</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>
  </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>
      <group_list>
        <group group_id="P1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double-blind Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized But Not Treated</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="464">The number of participants who completed double-blind study drug.</participants>
                <participants group_id="P2" count="157">The number of participants who completed double-blind study drug.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Did Not Receive Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject Noncompliant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</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>
          <title>Open-label Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">not applicable to this arm</participants>
                <participants group_id="P2" count="157"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">not applicable to this arm</participants>
                <participants group_id="P2" count="150">The number of participants who completed open-label study drug.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <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="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Virologic Failure</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety population: all randomized participants who received at least 1 dose of blinded study drug</population>
      <group_list>
        <group group_id="B1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Double-blind placebo for 12 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="473"/>
            <count group_id="B2" value="158"/>
            <count group_id="B3" value="631"/>
          </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="49.4" spread="10.98"/>
                    <measurement group_id="B2" value="51.2" spread="10.23"/>
                    <measurement group_id="B3" value="49.9" spread="10.82"/>
                  </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="202"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="271"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="344"/>
                  </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 After 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 active study drug</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After 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>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded 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="473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.4"/>
                  </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>With a sample size of 450 subjects and assuming that 92% of the subjects in Arm A will achieve SVR12, this study has greater than 90% power to demonstrate non-inferiority with a 2-sided 95% lower confidence bound greater than 70% and greater than 90% power to demonstrate superiority with a 2-sided 95% lower confidence bound greater than 80% (based on the normal approximation of a single binomial proportion). 95% CI calculated using the normal approximation to the binomial distribution.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects administered telaprevir plus peginterferon (pegIFN)/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 70% to achieve noninferiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV, and the LCB of the 95% CI must have exceeded 80% to achieve superiority.</non_inferiority_desc>
            <param_type>Percentage of Participants with SVR12</param_type>
            <param_value>96.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.7</ci_lower_limit>
            <ci_upper_limit>98.1</ci_upper_limit>
            <estimate_desc>In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure was used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period</title>
        <description>Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.</description>
        <time_frame>At 12 weeks</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Double-blind placebo for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period</title>
          <description>Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.</description>
          <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug and had ALT ≥ ULN of the reference range at baseline were included in the analysis.</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="363"/>
                <count group_id="O2" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0"/>
                    <measurement group_id="O2" value="15.8"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <p_value_desc>In order to control the Type I error rate at 0.05, a fixed-sequence testing procedure will be used to proceed through the primary and first 3 secondary efficacy endpoints in the order numbered below.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After 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>Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1a who received at least 1 dose of blinded 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="322"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 75% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.</non_inferiority_desc>
            <param_type>Percentage of Participants with SVR12</param_type>
            <param_value>95.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>93.4</ci_lower_limit>
            <ci_upper_limit>97.9</ci_upper_limit>
            <estimate_desc>95% CI calculated using the normal approximation to the binomial distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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 active study drug</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After 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>Intent-to-treat (ITT) Population: All randomized participants in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm with HCV genotype 1b who received at least 1 dose of blinded 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="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="95.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>Based on historical SVR rates for noncirrhotic HCV treatment-naive subjects of the appropriate HCV genotype 1 subtype administered telaprevir plus pegIFN/RBV, the lower confidence bound (LCB) of the 95% confidence interval (CI) must have exceeded 84% to achieve superiority of the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN and RBV.</non_inferiority_desc>
            <param_type>Percentage of Participants with SVR12</param_type>
            <param_value>98.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.8</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% CI calculated using the normal approximation to the binomial distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</title>
        <description>Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA &lt; LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.</description>
        <time_frame>12 weeks after the last actual dose of active study drug</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</title>
          <description>Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA &lt; LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.</description>
          <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.</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="473"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.0" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</title>
        <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the 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 post-treatment</time_frame>
        <population>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA &lt; LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm</title>
          <description>Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the 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>Intent-to-treat (ITT) Population: All randomized participants who received at least 1 dose of blinded study drug with HCV RNA &lt; LLOQ at the final treatment visit who completed treatment in the Double-blind ABT-450/r/ABT-267 and ABT-333, plus RBV treatment arm.</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="463"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="0.4" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the start of active study drug administration (double-blind [DB]/open-label, OL active) to 30 days after the last dose of active study drug 16 weeks.</time_frame>
      <desc>DB Placebo Arm: AEs collected from start of placebo until 30 days following discontinuation of placebo and prior to the OL period (if applicable; total 16 weeks). Serious AES collected from informed consent until the end of participation in the study (12 weeks, DB period; 12 weeks, OL period + 48-week post-treatment period; total up to 72 weeks).</desc>
      <group_list>
        <group group_id="E1">
          <title>Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>Double Blind Placebo</title>
          <description>Double-blind placebo for 12 weeks</description>
        </group>
        <group group_id="E3">
          <title>Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 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="10" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="157"/>
              </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="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>SINUS TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>VENTRICULAR EXTRASYSTOLES</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>BILIARY COLIC</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>APPENDICITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>LOBAR PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>POSTOPERATIVE WOUND INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>SUBCUTANEOUS ABSCESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>LUMBAR VERTEBRAL FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>OVERDOSE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>NON-SMALL CELL LUNG CANCER</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>ENCEPHALOPATHY</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE RESPIRATORY FAILURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>MEDIASTINAL MASS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>AORTIC STENOSIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </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="391" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="108" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="117" subjects_at_risk="157"/>
              </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="24" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="112" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="164" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="157"/>
              </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="37" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="157"/>
              </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="23" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="156" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="157"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="67" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>SLEEP DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="157"/>
              </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="34" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="157"/>
              </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="27" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="157"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="473"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="158"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="157"/>
              </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/NCT01716585
org study id: M11-646
secondary id: 2012-002019-25
nct id: NCT01716585
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected
      treatment-naïve adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
time frame: 12 weeks after the last actual dose of active 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 Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
time frame: At 12 weeks
description: Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
measure: Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
time frame: 12 weeks after the last actual dose of active 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 HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
time frame: 12 weeks after the last actual dose of active 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 On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
time frame: 12 weeks after the last actual dose of active study drug
description: Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
measure: Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
time frame: Within 12 weeks post-treatment
description: Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the 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
arm group type: Experimental
description: Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
arm group type: Experimental
description: Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
intervention type: Drug
intervention name: ABT-450/r/ABT-267, ABT-333
description: ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
other name: ABT-267 also known as ombitasvir
other name: ABT-450 also known as paritaprevir
other name: ABT-333 also known as dasabuvir
other name: Viekira PAK
intervention type: Drug
intervention name: Ribavirin
description: Capsule (double-blind treatment period), tablet (open-label treatment period)
arm group label: ABT-450/r/ABT-267 and ABT-333, plus RBV
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
intervention type: Drug
intervention name: Placebo for ABT-450/r/ABT-267
description: Tablet
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
intervention type: Drug
intervention name: Placebo for ABT-333
description: Tablet
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
intervention type: Drug
intervention name: Placebo for ribavirin
description: Capsule
arm group label: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nancy Shulman, MD
role: Study Director
affiliation: AbbVie
country: Australia
country: Austria
country: Canada
country: France
country: Germany
country: Hungary
country: Italy
country: New Zealand
country: Spain
country: Sweden
country: Switzerland
country: United Kingdom
country: United States
url: http://rxabbvie.com
description: Related Info
citation: Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.
PMID: 24720703
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 