<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/NCT01674725</url>
  </required_header>
  <id_info>
    <org_study_id>M13-389</org_study_id>
    <secondary_id>2011-005740-95</secondary_id>
    <nct_id>NCT01674725</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C</brief_title>
  <acronym>PEARL-II</acronym>
  <official_title>A Randomized, Open-Label, Multicenter Study to Evaluate the Safety and Antiviral Activity of the Combination of ABT-450/Ritonavir/ABT-267 (ABT 450/r/ABT-267) and ABT-333 With and Without Ribavirin in Treatment-Experienced Subjects With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-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 antiviral activity of&#xD;
      ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267&#xD;
      also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin&#xD;
      (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without&#xD;
      cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of&#xD;
      the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without&#xD;
      ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C&#xD;
      virus genotype 1b (HCV GT1b) infection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 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 After Treatment; Primary Analyses</measure>
    <time_frame>12 weeks after last 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. The LLOQ for the assay was 25 IU/mL.&#xD;
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment</measure>
    <time_frame>Baseline (Day 1) and Week 12 (End of Treatment)</time_frame>
    <description>The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to &lt; LLN at the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses</measure>
    <time_frame>12 weeks after last 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.&#xD;
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Virologic Failure During Treatment</measure>
    <time_frame>Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12</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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure 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>Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)</time_frame>
    <description>Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (&lt;LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">187</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>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 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</arm_group_label>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, Plus RBV</arm_group_label>
    <other_name>ABT-450 also known as paritaprevir</other_name>
    <other_name>ABT-267 also known as ombitasvir</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>Tablet</description>
    <arm_group_label>ABT-450/r/ABT-267 and ABT-333, Plus RBV</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;
          -  Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to&#xD;
             10,000 IU/mL at screening)&#xD;
&#xD;
          -  Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co&#xD;
             infection with any other genotype/subgenotype.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant liver disease with any cause other than HCV as the primary cause&#xD;
&#xD;
          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody&#xD;
&#xD;
          -  Positive screen for drugs or alcohol&#xD;
&#xD;
          -  Use of contraindicated medications within 2 weeks of dosing&#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>Jeffrey Enejosa, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Turkey</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://rxabbvie.com</url>
    <description>Related Info</description>
  </link>
  <results_reference>
    <citation>Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L Jr, Hu YB, Podsadecki T, Bernstein B. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug;147(2):359-365.e1. doi: 10.1053/j.gastro.2014.04.045. Epub 2014 May 9.</citation>
    <PMID>24818763</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 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>Interferon-Free</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Ombitasvir</keyword>
  <keyword>Ribavirin</keyword>
  <keyword>Viekira PAK</keyword>
  <keyword>Dasabuvir</keyword>
  <keyword>Paritaprevir</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>
  </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>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="P2">
          <title>ABT-450/r/ABT-267 and ABT-333</title>
          <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 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="92"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did not receive study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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="0"/>
                <participants group_id="P2" count="1"/>
              </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</title>
          <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="B2">
          <title>ABT-450/r/ABT-267 and ABT-333</title>
          <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) 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="91"/>
            <count group_id="B2" value="95"/>
            <count group_id="B3" value="186"/>
          </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="54.2" spread="10.90"/>
                    <measurement group_id="B2" value="54.2" spread="10.51"/>
                    <measurement group_id="B3" value="54.2" spread="10.67"/>
                  </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="46"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="102"/>
                  </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; Primary Analyses</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. The LLOQ for the assay was 25 IU/mL.&#xD;
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.</description>
        <time_frame>12 weeks after last dose of study drug</time_frame>
        <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses</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. The LLOQ for the assay was 25 IU/mL.&#xD;
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.</description>
          <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.</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="88"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Planned enrollment is 210 to allow ≥200 GT1b-infected participants to be treated with combination formulation of ABT-450/r/ABT-267 and ABT-333 with and without RBV. Enrollment terminated after 187 participants were randomized. Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have &gt;90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.</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 at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.9</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Assuming a rate of 82% in each arm, a sample size of 90 participants per arm will have &gt;90% power to demonstrate noninferiority of each arm to the historical rate based on the normal approximation of a single binomial proportion in a one-sample test for superiority.</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 at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 64% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>97.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.6</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the normal approximation to the binomial distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment</title>
        <description>The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to &lt; LLN at the end of treatment.</description>
        <time_frame>Baseline (Day 1) and Week 12 (End of Treatment)</time_frame>
        <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment</title>
          <description>The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to &lt; LLN at the end of treatment.</description>
          <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b]) and had hemoglobin ≥ LLN reference range at baseline.</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="88"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.0"/>
                    <measurement group_id="O2" value="5.5"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses</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.&#xD;
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.</description>
        <time_frame>12 weeks after last dose of study drug</time_frame>
        <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses</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.&#xD;
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.</description>
          <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population); participants with missing data were counted as non-responders.</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="88"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7"/>
                    <measurement group_id="O2" value="100"/>
                  </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>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Percentage of Participants</param_type>
            <param_value>97.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.6</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Percentage of Participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>95.9</ci_lower_limit>
            <ci_upper_limit>100</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 75% to achieve superiority</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <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 at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333 treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%; the lower confidence bound of the 2-sided 95% confidence interval for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>2.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>5.4</ci_upper_limit>
            <estimate_desc>95% CI was calculated using the normal approximation to the binomial distribution.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Virologic Failure During Treatment</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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure 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, and 12</time_frame>
        <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Failure During Treatment</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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).</description>
          <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (intent-to-treat [ITT GT1b] population).</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="88"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rebound</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Failure to Suppress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </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 who completed treatment with plasma HCV RNA less than the lower limit of quantification (&lt;LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.</description>
        <time_frame>Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)</time_frame>
        <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA &lt; LLOQ at the final treatment visit and completed treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
          </group>
          <group group_id="O2">
            <title>ABT-450/r/ABT-267 and ABT-333</title>
            <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Virologic Relapse After Treatment</title>
          <description>Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (&lt;LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.</description>
          <population>All randomized participants with HCV subgenotype 1B (GT1b) infection who received at least 1 dose of coformulated ABT-450/r/ABT-267 and ABT-333, with or without RBV (ITT GT1b population) with HCV RNA &lt; LLOQ at the final treatment visit and completed treatment.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="4.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 64 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ABT-450/r/ABT-267 and ABT-333, Plus RBV</title>
          <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks</description>
        </group>
        <group group_id="E2">
          <title>ABT-450/r/ABT-267 and ABT-333</title>
          <description>ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) 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="2" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>PANCREATITIS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CELLULITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </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="1" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>NEPHROLITHIASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </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="71" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="95"/>
              </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="10" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>IRRITABILITY</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERBILIRUBINAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="95"/>
              </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="9" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </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="6" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="95"/>
              </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="3" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="95"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="95"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="95"/>
              </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</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/NCT01674725
org study id: M13-389
secondary id: 2011-005740-95
nct id: NCT01674725
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety and antiviral activity 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) with and without ribavirin
      (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without
      cirrhosis.
A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of
      the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without
      ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C
      virus genotype 1b (HCV GT1b) infection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Primary Analyses
time frame: 12 weeks after last 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. The LLOQ for the assay was 25 IU/mL.
The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b infection treated with telaprevir and peginterferon (pegIFN)/RBV.
measure: Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
time frame: Baseline (Day 1) and Week 12 (End of Treatment)
description: The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Secondary Analyses
time frame: 12 weeks after last 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.
The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333 with and without RBV) compared with the historical control rate for noncirrhotic, treatment-experienced participants with HCV GT1b treated with telaprevir and pegIFN/RBV; and the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333 compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
measure: Percentage of Participants With Virologic Failure During Treatment
time frame: Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12
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 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure 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: Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-Treatment)
description: Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period. 95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 0%.
arm group label: ABT-450/r/ABT-267 and ABT-333, Plus RBV
arm group type: Experimental
description: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
arm group label: ABT-450/r/ABT-267 and ABT-333
arm group type: Experimental
description: ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 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
arm group label: ABT-450/r/ABT-267 and ABT-333, Plus RBV
other name: ABT-450 also known as paritaprevir
other name: ABT-267 also known as ombitasvir
other name: ABT-333 also known as dasabuvir
other name: Viekira PAK
intervention type: Drug
intervention name: Ribavirin
description: Tablet
arm group label: 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: Jeffrey Enejosa, MD
role: Study Director
affiliation: AbbVie
country: Austria
country: Belgium
country: Italy
country: Netherlands
country: Portugal
country: Puerto Rico
country: Sweden
country: Switzerland
country: Turkey
country: United States
url: http://rxabbvie.com
description: Related Info
citation: Andreone P, Colombo MG, Enejosa JV, Koksal I, Ferenci P, Maieron A, Mullhaupt B, Horsmans Y, Weiland O, Reesink HW, Rodrigues L Jr, Hu YB, Podsadecki T, Bernstein B. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology. 2014 Aug;147(2):359-365.e1. doi: 10.1053/j.gastro.2014.04.045. Epub 2014 May 9.
PMID: 24818763
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: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 