<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/NCT02219503</url>
  </required_header>
  <id_info>
    <org_study_id>M14-490</org_study_id>
    <secondary_id>2014-001953-18</secondary_id>
    <nct_id>NCT02219503</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis</brief_title>
  <acronym>TURQUOISE-III</acronym>
  <official_title>An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)</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>
      The purpose of this study was to evaluate the safety and efficacy of ombitasvir/&#xD;
      paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus&#xD;
      (HCV) infection and cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a multicenter study evaluating the efficacy and safety of ombitasvir/&#xD;
      paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b&#xD;
      (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV)&#xD;
      treatment-experienced adults with compensated cirrhosis. The duration of the study was up to&#xD;
      36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week&#xD;
      Treatment Period and a 24-week Post-Treatment Period for all participants who received study&#xD;
      drugs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 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.&#xD;
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.</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">60</enrollment>
  <condition>Chronic Hepatitis C Infection</condition>
  <condition>Compensated Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir</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) administered 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</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</arm_group_label>
    <other_name>ABT-333</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is&#xD;
             defined as the following:&#xD;
&#xD;
               -  Positive for anti-HCV antibody (Ab) or HCV RNA &gt; 1,000 IU/mL at least 6 months&#xD;
                  before Screening, and positive for HCV RNA and anti-HCV Ab at the time of&#xD;
                  Screening; or&#xD;
&#xD;
               -  HCV RNA &gt; 1,000 IU/mL at the time of Screening with a liver biopsy consistent&#xD;
                  with chronic HCV-infection (or a liver biopsy performed prior to enrollment with&#xD;
                  evidence of chronic hepatitis C disease).&#xD;
&#xD;
          2. Screening laboratory result indicating HCV genotype 1b-infection.&#xD;
&#xD;
          3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant or breastfeeding.&#xD;
&#xD;
          2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human&#xD;
             immunodeficiency virus (HIV) antibody (confirmed by Western Blot).&#xD;
&#xD;
          3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical&#xD;
             history of liver decompensation such as ascites (noted on physical exam), variceal&#xD;
             bleeding, or hepatic encephalopathy.&#xD;
&#xD;
          4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as&#xD;
             computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months&#xD;
             prior to Screening or on an ultrasound performed at Screening (a positive ultrasound&#xD;
             result will be confirmed with CT scan or MRI.)&#xD;
&#xD;
          5. Use of contraindicated medications within 2 weeks of dosing&#xD;
&#xD;
          6. Screening laboratory analyses showing any of the following abnormal laboratory&#xD;
             results:&#xD;
&#xD;
               -  Calculated creatinine clearance (using Cockcroft-Gault method) &lt; 30 mL/min&#xD;
&#xD;
               -  Albumin &lt; 2.8 g/dL&#xD;
&#xD;
               -  International normalized ratio (INR) &gt; 1.8. Participants with a known inherited&#xD;
                  blood disorder and INR &gt; 1.8 may be enrolled with permission of the AbbVie Study&#xD;
                  Designated Physician.&#xD;
&#xD;
               -  Hemoglobin &lt; 10 g/dL&#xD;
&#xD;
               -  Platelets &lt; 25,000 cells per mm3&#xD;
&#xD;
               -  Total bilirubin &gt; 3.0 mg/dL&#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>Roger Trinh, MD</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <removed_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://www.rxabbvie.com/</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.</citation>
    <PMID>26476290</PMID>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 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>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis C</keyword>
  <keyword>Chronic Hepatitis C</keyword>
  <keyword>Compensated Cirrhosis</keyword>
  <keyword>Cirrhotic</keyword>
  <keyword>Hepatitis C Genotype 1b</keyword>
  <keyword>Hepatitis C Virus</keyword>
  <keyword>Interferon-Free</keyword>
  <keyword>Child Pugh A</keyword>
  <keyword>Ribavirin-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>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 60 subjects were enrolled and all the subjects completed the study. All 60 subjects 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</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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="60"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
              </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</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="60"/>
          </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="59.5" spread="9.53"/>
                  </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="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Interleukin 28B (IL28B) Genotype</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>CC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </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.&#xD;
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.</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</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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.&#xD;
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.</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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="94.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Non-inferiority was to be declared if the lower confidence bound was greater than 72.7%.</non_inferiority_desc>
            <param_type>Percentage of Participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.0</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>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The superiority of the Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir regimen in SVR12 to a historical threshold for sofosbuvir plus pegIFN/ ribavirin (RBV) for the treatment of participants with HCV Genotype 1b (GT1b) infection and cirrhosis was calculated using a 2-sided 95% CI from Wilson's score method. Superiority was declared if the lower confidence bound was greater than 83.2%.</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <param_type>Percentage of Participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>94.0</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</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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="60"/>
              </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="6.0"/>
                  </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</title>
            <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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="60"/>
              </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="6.0"/>
                  </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 42 weeks).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir</title>
          <description>Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="60"/>
              </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="3" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>INFLUENZA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="60"/>
              </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="4" subjects_at_risk="60"/>
              </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="6" subjects_at_risk="60"/>
              </event>
              <event>
                <sub_title>PRURITUS GENERALISED</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="60"/>
              </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/NCT02219503
org study id: M14-490
secondary id: 2014-001953-18
nct id: NCT02219503
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/
      paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus
      (HCV) infection and cirrhosis.
This was a multicenter study evaluating the efficacy and safety of ombitasvir/
      paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b
      (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV)
      treatment-experienced adults with compensated cirrhosis. The duration of the study was up to
      36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week
      Treatment Period and a 24-week Post-Treatment Period for all participants who received study
      drugs.
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.
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
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
arm group type: Experimental
description: Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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
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
other name: ABT-333
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Trinh, MD
role: Study Director
affiliation: AbbVie
country: Belgium
country: Canada
country: United States
url: http://www.rxabbvie.com/
description: Related Info
citation: Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.
PMID: 26476290
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: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Ritonavir
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 