<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/NCT02265237</url>
  </required_header>
  <id_info>
    <org_study_id>M11-665</org_study_id>
    <secondary_id>2014-001496-31</secondary_id>
    <nct_id>NCT02265237</nct_id>
  </id_info>
  <brief_title>A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)</brief_title>
  <acronym>AGATE-1</acronym>
  <official_title>A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis&#xD;
      is to assess the safety and to compare the percentage of participants achieving a 12-week&#xD;
      sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) &lt; lower limit of&#xD;
      quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold&#xD;
      [based on SVR rates for HCV genotype 4-infected participants treated with pegylated&#xD;
      interferon (pegIFN)/RBV].&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and&#xD;
      efficacy of ombitasvir/paritaprevir/ritonavir coadministered with RBV for 12, 16, or 24 weeks&#xD;
      in HCV genotype 4 (GT4)-infected participants with compensated cirrhosis who are either&#xD;
      treatment-naïve or who had previously received only IFN/RBV treatment for HCV.&#xD;
&#xD;
      The study also enrolled HCV GT4-infected participants with compensated cirrhosis who had&#xD;
      previously experienced virologic failure with either SOF/pegIFN/RBV or sofosbuvir (SOF)/RBV&#xD;
      treatment. These participants were treated with ombitasvir/paritaprevir/ritonavir&#xD;
      coadministered with RBV for 24 weeks in this study.&#xD;
&#xD;
      This study was divided into 2 parts with approximately 184 total participants. Part I&#xD;
      included participants who were randomized to receive either 12 or 16 weeks of treatment and&#xD;
      Part II included participants who received 24 weeks of treatment. Enrollment into Part II&#xD;
      opened once randomization in Part I was completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 28, 2014</start_date>
  <completion_date type="Actual">April 7, 2017</completion_date>
  <primary_completion_date type="Actual">July 28, 2016</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 in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)</measure>
    <time_frame>12 weeks after the last actual dose of study drug</time_frame>
    <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure</measure>
    <time_frame>Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment</time_frame>
    <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA &gt;= LLOQ with at least 6 weeks of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Arms A, B and C With Post-treatment Relapse</measure>
    <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
    <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Hepatitis C Virus</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ombitasvir/paritaprevir/ritonavir</intervention_name>
    <description>tablets</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
    <other_name>norvir (ritonavir)</other_name>
    <other_name>paritaprevir (ABT-450)</other_name>
    <other_name>ombitasvir (ABT-267)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ribavirin</intervention_name>
    <description>tablets</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_label>Arm C</arm_group_label>
    <arm_group_label>Arm D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For Arms A, B and C:&#xD;
&#xD;
        - Participants must meet one of the following:&#xD;
&#xD;
          -  Treatment-naive: Participant has never received antiviral treatment for hepatitis C&#xD;
             infection OR&#xD;
&#xD;
          -  Treatment Experienced (Prior null responders, Partial responders or Relapsers to&#xD;
             IFN/RBV);&#xD;
&#xD;
        For Arm D:&#xD;
&#xD;
        - Participant must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet&#xD;
        one of the following categories:&#xD;
&#xD;
          -  Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with&#xD;
             SOF/pegIFN/RBV or SOF/RBV;&#xD;
&#xD;
          -  Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course&#xD;
             SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following&#xD;
             completion of therapy.&#xD;
&#xD;
        For Arms A, B, C and D:&#xD;
&#xD;
          -  Chronic HCV genotype 4 infection with cirrhosis.&#xD;
&#xD;
          -  Participant has plasma HCV RNA level &gt; 1,000 IU/mL at Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or&#xD;
             anti-human immunodeficiency virus antibody (HIV Ab).&#xD;
&#xD;
          -  Current enrollment in another interventional clinical study, previous enrollment in&#xD;
             this study, or previous use of any protease inhibitor, non-nucleoside polymerase&#xD;
             inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational or&#xD;
             commercially available (including previous exposure to paritaprevir or ombitasvir), or&#xD;
             receipt of any investigational product within 6 weeks prior to study drug&#xD;
             administration. Prior use of any direct-acting antiviral will not be allowed, except&#xD;
             for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir&#xD;
             with pegIFN/RBV or SOF with RBV is required.&#xD;
&#xD;
          -  Any current or past clinical evidence of Child-Pugh B or C classification or clinical&#xD;
             history of liver decompensation including ascites, variceal bleeding, or hepatic&#xD;
             encephalopathy.&#xD;
&#xD;
          -  Confirmed presence of hepatocellular carcinoma.&#xD;
&#xD;
          -  Any cause of liver disease other than chronic HCV infection.&#xD;
&#xD;
          -  Abnormal laboratory tests.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </removed_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>October 10, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <results_first_submitted>April 26, 2017</results_first_submitted>
  <results_first_submitted_qc>August 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2017</results_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Hepatitis C Genotype 4</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was divided into 2 parts with 184 total participants. Part I (Arms A and B) included participants who received either 12 or 16 weeks of treatment and Part II (Arms C and D) included participants who received 24 weeks of treatment. Enrollment into Part II opened once randomization in Part I was completed.</recruitment_details>
      <pre_assignment_details>Safety analysis population: all participants who received at least 1 dose of study drug. One participant randomized to the arm B (16 weeks arm) was erroneously administered study drug for 12 weeks (as in arm A). Therefore this participant is included in arm A for the safety population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="P2">
          <title>Arm B</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="P3">
          <title>Arm C</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="P4">
          <title>Arm D</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>As Enrolled (Overall Study)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="61"/>
                <participants group_id="P3" count="61"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>As Treated (Overall Study)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="60">One arm B subject received the drug for the duration for arm A and was included in arm A for safety.</participants>
                <participants group_id="P2" count="60">One arm B subject received the drug for the duration for arm A and was included in arm A for safety.</participants>
                <participants group_id="P3" count="61"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="57"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" 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="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" 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 group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis population: all participants who received at least 1 dose of study drug. One participant randomized to arm B (16 weeks arm) was erroneously administered study drug for 12 weeks (as in arm A). Therefore this participant is included in arm A for the safety population.</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="B2">
          <title>Arm B</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="B3">
          <title>Arm C</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="B4">
          <title>Arm D</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.</description>
        </group>
        <group group_id="B5">
          <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="60"/>
            <count group_id="B2" value="60"/>
            <count group_id="B3" value="61"/>
            <count group_id="B4" value="3"/>
            <count group_id="B5" value="184"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.7" spread="8.08"/>
                    <measurement group_id="B2" value="57.1" spread="9.08"/>
                    <measurement group_id="B3" value="54.6" spread="9.02"/>
                    <measurement group_id="B4" value="62.3" spread="8.08"/>
                    <measurement group_id="B5" value="56.6" spread="8.80"/>
                  </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="14"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (&lt;LLOQ) 12 weeks after the last dose of study drug.</description>
          <population>Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6" lower_limit="86.7" upper_limit="99.2"/>
                    <measurement group_id="O2" value="100.0" lower_limit="92.4" upper_limit="100.0"/>
                    <measurement group_id="O3" value="93.4" lower_limit="82.6" upper_limit="97.7"/>
                  </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>The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>100</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>92.4</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>The confidence interval was calculated using the Wilson score method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>97.5% confidence interval (CI) was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV GT4-infected subjects treated with pegIFN/RBV.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>96.6</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>86.7</ci_lower_limit>
            <ci_upper_limit>99.2</ci_upper_limit>
            <estimate_desc>The confidence interval was calculated using the Wilson score method.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The overall 2-sided significance level of 0.05 was split between Part I (arms A and B) and Part II (arm C) using a Bonferroni corrected alpha level of 0.025 for each part. Additionally, a fixed sequence procedure for Part I was used to proceed through the primary efficacy comparisons in the following order: 1) test of superiority of arm B and 2) test of superiority of arm A. The primary outcome within Arm C was tested with a Bonferroni-corrected Type 1 error rate of 0.025 for superiority.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>97.5% CI was calculated using the Wilson score method; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 67% to achieve superiority. The predefined threshold of 67% was based on historical SVR rates for HCV genotype 4 (GT4)-infected subjects treated with pegIFN/RBV.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>93.4</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>82.6</ci_lower_limit>
            <ci_upper_limit>97.7</ci_upper_limit>
            <estimate_desc>The confidence interval was calculated using the Wilson score method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.</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="59"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6"/>
                    <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>O2</group_id>
            </group_id_list>
            <groups_desc>Within Part I (arm A and B), since superiority was demonstrated for both arms in the primary outcome measures, testing continued to the first secondary outcome measure.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel (MH) proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).</non_inferiority_desc>
            <p_value>0.304</p_value>
            <method>Mantel Haenszel</method>
            <param_type>Stratum-Adjusted MH Difference</param_type>
            <param_value>-3.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.85</ci_lower_limit>
            <ci_upper_limit>3.07</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)</title>
        <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
        <time_frame>12 weeks after the last actual dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm B</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O2">
            <title>Arm C</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)</title>
          <description>SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [&lt;LLOQ]) 12 weeks after the last dose of study drug.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population); participants with missing data after backwards imputation were imputed as nonresponders.</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="61"/>
                <count group_id="O2" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="93.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Within Part II (arm C), since superiority was demonstrated for the primary outcome measure, testing continued to the second secondary outcome measure.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Treatment differences (with 95% confidence intervals) and corresponding P-value for the specified comparisons were estimated using stratum adjusted Mantel-Haenszel proportion and continuity-corrected variance, adjusting for IFN/RBV treatment history (treatment-naïve or treatment-experienced).</non_inferiority_desc>
            <p_value>0.086</p_value>
            <method>Mantel Haenszel</method>
            <param_type>Stratum-Adjusted MH Difference</param_type>
            <param_value>6.45</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.91</ci_lower_limit>
            <ci_upper_limit>13.81</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure</title>
        <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA &gt;= LLOQ with at least 6 weeks of treatment.</description>
        <time_frame>Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population).</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure</title>
          <description>On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA &lt; LLOQ during treatment; confirmed increase of &gt; 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA &gt;= LLOQ with at least 6 weeks of treatment.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population).</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.3" upper_limit="9.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="5.9"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants in Arms A, B and C With Post-treatment Relapse</title>
        <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
        <time_frame>From the end of treatment through 12 weeks after the last dose of study drug</time_frame>
        <population>All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Arm A</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O2">
            <title>Arm B</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
          </group>
          <group group_id="O3">
            <title>Arm C</title>
            <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants in Arms A, B and C With Post-treatment Relapse</title>
          <description>Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels &lt; LLOQ at the end of treatment.</description>
          <population>All participants who received at least 1 dose of study drug (ITT population) with at least one post-treatment HCV RNA value, completed treatment, and had HCV RNA &lt;LLOQ at the final treatment visit.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="56"/>
              </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="6.3"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="6.1"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 28 weeks)</time_frame>
      <desc>TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug. TEAEs were collected whether elicited or spontaneously reported by the participant.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm A</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="E2">
          <title>Arm B</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="E3">
          <title>Arm C</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.</description>
        </group>
        <group group_id="E4">
          <title>Arm D</title>
          <description>Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMORRHAGIC ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE CORONARY SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MYOCARDIAL INFARCTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>OESOPHAGEAL VARICES HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATOTOXICITY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PORTAL VEIN THROMBOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>CLOSTRIDIUM COLITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MENINGITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PNEUMONIA KLEBSIELLA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>INTERVERTEBRAL DISC PROTRUSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>SCIATICA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>MANIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SUICIDAL IDEATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SUICIDE ATTEMPT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="3"/>
              </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="7" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>EAR PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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="60"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INFLUENZA LIKE ILLNESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>JAUNDICE</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HAEMOGLOBIN DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HYPERGLYCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>MEMORY IMPAIRMENT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>SLEEP DISORDER</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PARANASAL SINUS DISCOMFORT</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </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="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>PRURITUS GENERALISED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>RASH</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="61"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="3"/>
              </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/NCT02265237
org study id: M11-665
secondary id: 2014-001496-31
nct id: NCT02265237
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis
      is to assess the safety and to compare the percentage of participants achieving a 12-week
      sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of
      quantification (LLOQ) 12 weeks following treatment], to a clinically relevant threshold
      [based on SVR rates for HCV genotype 4-infected participants treated with pegylated
      interferon (pegIFN)/RBV].
This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and
      efficacy of ombitasvir/paritaprevir/ritonavir coadministered with RBV for 12, 16, or 24 weeks
      in HCV genotype 4 (GT4)-infected participants with compensated cirrhosis who are either
      treatment-naïve or who had previously received only IFN/RBV treatment for HCV.

      The study also enrolled HCV GT4-infected participants with compensated cirrhosis who had
      previously experienced virologic failure with either SOF/pegIFN/RBV or sofosbuvir (SOF)/RBV
      treatment. These participants were treated with ombitasvir/paritaprevir/ritonavir
      coadministered with RBV for 24 weeks in this study.

      This study was divided into 2 parts with approximately 184 total participants. Part I
      included participants who were randomized to receive either 12 or 16 weeks of treatment and
      Part II included participants who received 24 weeks of treatment. Enrollment into Part II
      opened once randomization in Part I was completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)
time frame: 12 weeks after the last actual dose of study drug
description: SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
measure: Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure
time frame: Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment
description: On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or all on-treatment values of HCV RNA >= LLOQ with at least 6 weeks of treatment.
measure: Percentage of Participants in Arms A, B and C With Post-treatment Relapse
time frame: From the end of treatment through 12 weeks after the last dose of study drug
description: Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment.
arm group label: Arm A
arm group type: Experimental
description: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
arm group label: Arm B
arm group type: Experimental
description: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
arm group label: Arm C
arm group type: Experimental
description: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
arm group label: Arm D
arm group type: Experimental
description: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
intervention type: Drug
intervention name: ombitasvir/paritaprevir/ritonavir
description: tablets
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
other name: norvir (ritonavir)
other name: paritaprevir (ABT-450)
other name: ombitasvir (ABT-267)
intervention type: Drug
intervention name: ribavirin
description: tablets
arm group label: Arm A
arm group label: Arm B
arm group label: Arm C
arm group label: Arm D
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
country: Austria
country: Belgium
country: Canada
country: France
country: Germany
country: Greece
country: Italy
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Fibrosis
mesh term: Ritonavir
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 