<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/NCT02216422</url>
  </required_header>
  <id_info>
    <org_study_id>M14-252</org_study_id>
    <nct_id>NCT02216422</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection</brief_title>
  <acronym>Turquoise-IV</acronym>
  <official_title>An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a multicenter study evaluating the efficacy and safety of&#xD;
      ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12&#xD;
      weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV&#xD;
      treatment-experienced, cirrhotic HCV genotype 1b-infected adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study was to assess the safety and efficacy (the percentage of&#xD;
      participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid&#xD;
      (RNA) &lt; lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated&#xD;
      ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir&#xD;
      co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with&#xD;
      compensated cirrhosis. The secondary objectives of this study were to assess the number and&#xD;
      percentage of participants with virologic failure during treatment and the percentage of&#xD;
      participants with relapse post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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 (SVR12) Post-treatment</measure>
    <time_frame>Post-treatment Day 1 to Post-treatment Week 12</time_frame>
    <description>Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (&lt; LLOQ; &lt; 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With On-Treatment Virologic Failure</measure>
    <time_frame>Day 1 through Week 12</time_frame>
    <description>On-Treatment Virologic Failure is defined as confirmed HCV RNA &gt;= LLOQ after HCV RNA &lt; LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA &gt;= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Post-Treatment Relapse</measure>
    <time_frame>Post-treatment Day 1 to Post-treatment Week 12</time_frame>
    <description>Post- Treatment Relapse is defined as confirmed HCV RNA &gt;= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA &lt; LLOQ at Final Treatment Visit who completes treatment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Chronic Hepatitis C Virus (HCV) Infection</condition>
  <arm_group>
    <arm_group_label>Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ombitasvir/Paritaprevir/Ritonavir</intervention_name>
    <description>Tablet; paritaprevir co-formulated with ritonavir and ombitasvir</description>
    <arm_group_label>Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV</arm_group_label>
    <other_name>ABT-267 also known as ombitasvir</other_name>
    <other_name>ABT-450 also known as paritaprevir</other_name>
    <other_name>Ritonavir also known as norvir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dasabuvir</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV</arm_group_label>
    <other_name>ABT-333</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>Tablet</description>
    <arm_group_label>Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at&#xD;
             Screening)&#xD;
&#xD;
          -  Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh&#xD;
             score less than or equal to 6 at Screening&#xD;
&#xD;
          -  Participant had never received antiviral treatment (including pegIFN/RBV) for&#xD;
             hepatitis C infection (treatment-naïve participant) or had documentation of meeting&#xD;
             one of the defined categories of a treatment-experienced participants&#xD;
&#xD;
          -  Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound,&#xD;
             computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3&#xD;
             months prior to screening or a negative ultrasound at screening.&#xD;
&#xD;
          -  Females must be post-menopausal, of non-child bearing potential or practicing specific&#xD;
             forms of birth control&#xD;
&#xD;
          -  Males must have been surgically sterile, or agreed to practice 2 effective methods of&#xD;
             birth control throughout the course of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus&#xD;
             antibody&#xD;
&#xD;
          -  Evidence of current or past Child-Pugh B or C classification&#xD;
&#xD;
          -  Confirmed presence of hepatocellular carcinoma&#xD;
&#xD;
          -  Abnormal laboratory tests&#xD;
&#xD;
          -  Participant who self-reported on average drinking more than 2 drinks per day for&#xD;
             current drinkers&#xD;
&#xD;
          -  Previous treatment with a direct acting antiviral agent (DAA) containing regimen&#xD;
&#xD;
          -  History of solid organ transplant.&#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>Rolando M Viani, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Belarus</country>
    <country>Russian Federation</country>
  </removed_countries>
  <link>
    <url>http://www.rxabbvie.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <results_first_submitted>May 23, 2016</results_first_submitted>
  <results_first_submitted_qc>May 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 29, 2016</results_first_posted>
  <last_update_submitted>May 23, 2016</last_update_submitted>
  <last_update_submitted_qc>May 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>Hepatitis C Genotype 1b</keyword>
  <keyword>Interferon-Free</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 36 participants were enrolled and all the participants completed the study. All 36 participants were analyzed for both efficacy (included all participants who received at least 1 dose of study drug (ITT)) and safety.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; 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="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Baseline analyses included all participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="36"/>
          </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="51.6" spread="7.91"/>
                  </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="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interleukin 28B (IL28B)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </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 (SVR12) Post-treatment</title>
        <description>Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (&lt; LLOQ; &lt; 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.</description>
        <time_frame>Post-treatment Day 1 to Post-treatment Week 12</time_frame>
        <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</population>
        <group_list>
          <group group_id="O1">
            <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment</title>
          <description>Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (&lt; LLOQ; &lt; 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.</description>
          <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</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="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="90.4" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</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>90.4</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>95% confidence interval (CI) was calculated using Wilson score method.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With On-Treatment Virologic Failure</title>
        <description>On-Treatment Virologic Failure is defined as confirmed HCV RNA &gt;= LLOQ after HCV RNA &lt; LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA &gt;= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.</description>
        <time_frame>Day 1 through Week 12</time_frame>
        <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</population>
        <group_list>
          <group group_id="O1">
            <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With On-Treatment Virologic Failure</title>
          <description>On-Treatment Virologic Failure is defined as confirmed HCV RNA &gt;= LLOQ after HCV RNA &lt; LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements &gt; 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA &gt;= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.</description>
          <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</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="36"/>
              </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="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Post-Treatment Relapse</title>
        <description>Post- Treatment Relapse is defined as confirmed HCV RNA &gt;= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA &lt; LLOQ at Final Treatment Visit who completes treatment.</description>
        <time_frame>Post-treatment Day 1 to Post-treatment Week 12</time_frame>
        <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</population>
        <group_list>
          <group group_id="O1">
            <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Post-Treatment Relapse</title>
          <description>Post- Treatment Relapse is defined as confirmed HCV RNA &gt;= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA &lt; LLOQ at Final Treatment Visit who completes treatment.</description>
          <population>Efficacy analyses included all participants who received at least 1 dose of study drug (ITT).</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="36"/>
              </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="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs and SAEs were collected from the time of study drug administration to 30 days after last dose of study drug (12 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (up to 36 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ombitasvir/Paritaprevir/Ritonavir Plus</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="36"/>
              </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="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LEUKOPENIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>ASTHENIA</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERBILIRUBINAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>UPPER RESPIRATORY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </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="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </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="36"/>
              </event>
              <event>
                <sub_title>DYSPNOEA EXERTIONAL</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
              </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="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Medical Services</name_or_title>
      <organization>AbbVie</organization>
      <phone>800-633-9110</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216422
org study id: M14-252
nct id: NCT02216422
lead sponsor: 
has dmc: No
This was a multicenter study evaluating the efficacy and safety of
      ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12
      weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV
      treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
The primary objective of this study was to assess the safety and efficacy (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]) of co-formulated
      ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir
      co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with
      compensated cirrhosis. The secondary objectives of this study were to assess the number and
      percentage of participants with virologic failure during treatment and the percentage of
      participants with relapse post-treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
time frame: Post-treatment Day 1 to Post-treatment Week 12
description: Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
measure: Percentage of Participants With On-Treatment Virologic Failure
time frame: Day 1 through Week 12
description: On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.
measure: Percentage of Participants With Post-Treatment Relapse
time frame: Post-treatment Day 1 to Post-treatment Week 12
description: Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.
arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
arm group type: Experimental
description: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks
intervention type: Drug
intervention name: Ombitasvir/Paritaprevir/Ritonavir
description: Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
other name: ABT-267 also known as ombitasvir
other name: ABT-450 also known as paritaprevir
other name: Ritonavir also known as norvir
intervention type: Drug
intervention name: Dasabuvir
description: Tablet
arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
other name: ABT-333
intervention type: Drug
intervention name: Ribavirin (RBV)
description: Tablet
arm group label: Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rolando M Viani, MD
role: Study Director
affiliation: AbbVie
country: Belarus
country: Russian Federation
url: http://www.rxabbvie.com/
description: Related Info
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Ritonavir
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 