<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/NCT01728324</url>
  </required_header>
  <id_info>
    <org_study_id>1241.36</org_study_id>
    <secondary_id>2012-003535-27</secondary_id>
    <nct_id>NCT01728324</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2</brief_title>
  <official_title>A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI&#xD;
      207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically&#xD;
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">February 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SVR12 Rates With Historical Control</measure>
    <time_frame>12 Week (post-treatment)</time_frame>
    <description>Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level &lt;25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.&#xD;
The number of participants analyzed are actually adjusted number of participant analyzed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparisons of SVR12 Rates Across Treatment Arms</measure>
    <time_frame>12 Week (post-treatment)</time_frame>
    <description>Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SVR4: Plasma HCV RNA Level &lt;25 IU/mL at 4 Weeks After EOT.</measure>
    <time_frame>4 weeks (after End Of Treatment)</time_frame>
    <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level &lt;25 IU/mL at 4 weeks after EOT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SVR24: Plasma HCV RNA Level &lt;25 IU/mL at 24 Weeks After EOT.</measure>
    <time_frame>4 weeks (after End Of Treatment)</time_frame>
    <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level &lt;25 IU/mL at 24 weeks after EOT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prognostic Value of SVR12 Predicting SVR24</measure>
    <time_frame>24 Week (post-treatment)</time_frame>
    <description>The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">496</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Randomised 24-week arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 207127 in combination with FDV and RBV for 24 weeks (randomised)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allocated 24-week arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127-placebo: 8-week treatment</intervention_name>
    <description>8 weeks of placebo treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Allocated 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Randomised 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faldaprevir: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Allocated 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faldaprevir: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Randomised 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin-placebo: 8-week treatment</intervention_name>
    <description>8 weeks of placebo treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Allocated 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faldaprevir-placebo: 8-week treatment</intervention_name>
    <description>8 weeks of placebo treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faldaprevir: 16-week treatment</intervention_name>
    <description>16 weeks of active treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin: 16-week treatment</intervention_name>
    <description>16 weeks of active treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RBV: 24-week treatment</intervention_name>
    <description>24 weeks of active treatment</description>
    <arm_group_label>Randomised 24-week arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127: 16-week treatment</intervention_name>
    <description>16 weeks of active treatment</description>
    <arm_group_label>Randomised 16-week arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected&#xD;
             HCV RNA at screening&#xD;
&#xD;
          2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.&#xD;
&#xD;
          3. HCV viral load =1,000 IU/mL at randomisation.&#xD;
&#xD;
          4. Patients who have never been previously treated with any other HCV treatment regimen.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at&#xD;
             screening.&#xD;
&#xD;
          2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.&#xD;
&#xD;
          3. Liver disease due to causes other than chronic HCV infection.&#xD;
&#xD;
          4. HIV infection.&#xD;
&#xD;
          5. Hepatitis B virus infection based on presence of HBs-Ag.&#xD;
&#xD;
          6. Confirmed or suspected active malignancy or history of malignancy within the last 5&#xD;
             years prior to screening.&#xD;
&#xD;
          7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12&#xD;
             months prior to randomisation.&#xD;
&#xD;
          8. Subject is not willing to comply with the precautionary measures to prevent&#xD;
             photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).&#xD;
&#xD;
          9. Decompensated liver disease, or history of decompensated liver disease.&#xD;
&#xD;
         10. Clinical evidence of unstable cardiovascular disease which may further decompensate&#xD;
             due to anemia.&#xD;
&#xD;
         11. Red blood cell disorders.&#xD;
&#xD;
         12. Body weight &lt;40 kg or &gt;125 kg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1241.36.00016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>North Little Rock</city>
        <state>Arkansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00020 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00034 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Deland</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Palm Harbor</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00030 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Zephyrhills</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00027 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00033 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00035 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Valparaiso</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00017 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00018 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00043 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hillsborough</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00039 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00031 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00026 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00044 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.00029 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Camperdown</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kogarah</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>New Lambton</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Randwick</city>
        <state>New South Wales</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Darlinghurst</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.61006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bruxelles</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Edegem</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Leuven</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Liège</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.32007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Roeselare</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.01005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.01006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.01002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.36.01003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
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      <address>
        <city>Plymouth</city>
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  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>New Zealand</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
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  <removed_countries>
    <country>Korea, Republic of</country>
  </removed_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 19, 2012</study_first_posted>
  <results_first_submitted>January 14, 2016</results_first_submitted>
  <results_first_submitted_qc>January 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 12, 2016</results_first_posted>
  <disposition_first_submitted>June 25, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>June 25, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 26, 2014</disposition_first_posted>
  <last_update_submitted>January 14, 2016</last_update_submitted>
  <last_update_submitted_qc>January 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
        </group>
        <group group_id="P2">
          <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
        </group>
        <group group_id="P3">
          <title>24-wk Cirrhotic (CR) Treatment Group</title>
          <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Termination of DBV</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="213"/>
                <participants group_id="P3" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="177"/>
                <participants group_id="P3" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than stated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Termination of FDV</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="213"/>
                <participants group_id="P3" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="173"/>
                <participants group_id="P2" count="177"/>
                <participants group_id="P3" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than stated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Termination of RBV</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="211"/>
                <participants group_id="P2" count="213"/>
                <participants group_id="P3" count="72"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="176"/>
                <participants group_id="P3" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than stated</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation (Placebo Period)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS): This analysis set includes all randomized patients who were dispensed study medication and were documented to have taken at least one dose of any study medication, either active or placebo.</population>
      <group_list>
        <group group_id="B1">
          <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
        </group>
        <group group_id="B2">
          <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
        </group>
        <group group_id="B3">
          <title>24-wk Cirrhotic (CR) Treatment Group</title>
          <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
        </group>
        <group group_id="B4">
          <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="211"/>
            <count group_id="B2" value="213"/>
            <count group_id="B3" value="72"/>
            <count group_id="B4" value="496"/>
          </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="50.3" spread="12.5"/>
                    <measurement group_id="B2" value="50.5" spread="12.3"/>
                    <measurement group_id="B3" value="58.0" spread="8.8"/>
                    <measurement group_id="B4" value="51.5" spread="12.2"/>
                  </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="108"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="255"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>SVR12 Rates With Historical Control</title>
        <description>Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level &lt;25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.&#xD;
The number of participants analyzed are actually adjusted number of participant analyzed.</description>
        <time_frame>12 Week (post-treatment)</time_frame>
        <population>Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;</population>
        <group_list>
          <group group_id="O1">
            <title>24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group</title>
            <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group</title>
            <description>This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients</description>
          </group>
        </group_list>
        <measure>
          <title>SVR12 Rates With Historical Control</title>
          <description>Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level &lt;25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.&#xD;
The number of participants analyzed are actually adjusted number of participant analyzed.</description>
          <population>Modified full analysis set (mFAS): included patients in the full analysis set (FAS) who received at least one dose of active treatment;</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="283"/>
                <count group_id="O2" value="283"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PegIFN eligible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.95"/>
                    <measurement group_id="O2" value="76.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PegIFN ineligible</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.28"/>
                    <measurement group_id="O2" value="70.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>The proportion of patients achieving SVR12 achieved with 24 weeks of treatment with DBV/FDV/RBV in cirrhotic and non-cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>z-test</method>
            <method_desc>A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.</method_desc>
            <param_type>Adjusted response rate</param_type>
            <param_value>81.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.34</ci_lower_limit>
            <ci_upper_limit>85.87</ci_upper_limit>
            <estimate_desc>The adjusted response rate was tested against the historical control SVR rate of 68% (95% Confidence Interval (CI): 76.3, 85.9).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The proportion of patients achieving SVR12 achieved with 16 weeks of treatment of non-cirrhotic and 24 weeks of treatment of cirrhotic patients was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with PegIFN from historical data. The acceptable minimum SVR rate was an average of 71% (reference for PegIFN-eligible) and 50% (for PegIFN-ineligible patients), weighted by the sample size in each stratum.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0020</p_value>
            <method>z-test</method>
            <method_desc>A stratified one sample z-test with 50% reference for PegIFN-ineligible and 71% for PegIFN-eligible patients was performed.</method_desc>
            <param_type>Adjusted response rate</param_type>
            <param_value>75.89</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.63</ci_lower_limit>
            <ci_upper_limit>81.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Comparisons of SVR12 Rates Across Treatment Arms</title>
        <description>Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.</description>
        <time_frame>12 Week (post-treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
          </group>
          <group group_id="O3">
            <title>24-wk Cirrhotic (CR) Treatment Group</title>
            <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Comparisons of SVR12 Rates Across Treatment Arms</title>
          <description>Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.</description>
          <population>FAS</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="211"/>
                <count group_id="O2" value="213"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0" lower_limit="76.8" upper_limit="87.2"/>
                    <measurement group_id="O2" value="75.6" lower_limit="69.8" upper_limit="81.4"/>
                    <measurement group_id="O3" value="73.6" lower_limit="63.4" upper_limit="83.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0532</p_value>
            <method>Koch's method</method>
            <method_desc>Adjusted for PegIFN eligibility using Koch's method, with continuity correction.</method_desc>
            <param_type>SVR12 Rates difference</param_type>
            <param_value>6.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.4</ci_lower_limit>
            <ci_upper_limit>14.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SVR4: Plasma HCV RNA Level &lt;25 IU/mL at 4 Weeks After EOT.</title>
        <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level &lt;25 IU/mL at 4 weeks after EOT.</description>
        <time_frame>4 weeks (after End Of Treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
          </group>
          <group group_id="O3">
            <title>24-wk Cirrhotic (CR) Treatment Group</title>
            <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
          </group>
        </group_list>
        <measure>
          <title>SVR4: Plasma HCV RNA Level &lt;25 IU/mL at 4 Weeks After EOT.</title>
          <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level &lt;25 IU/mL at 4 weeks after EOT.</description>
          <population>FAS</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="211"/>
                <count group_id="O2" value="213"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.9" lower_limit="78.9" upper_limit="88.8"/>
                    <measurement group_id="O2" value="80.3" lower_limit="74.9" upper_limit="85.6"/>
                    <measurement group_id="O3" value="77.8" lower_limit="68.2" upper_limit="87.4"/>
                  </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>Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1671</p_value>
            <method>Koch´s method</method>
            <method_desc>Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.</method_desc>
            <param_type>SVR4 Rates difference</param_type>
            <param_value>3.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>10.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SVR24: Plasma HCV RNA Level &lt;25 IU/mL at 24 Weeks After EOT.</title>
        <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level &lt;25 IU/mL at 24 weeks after EOT.</description>
        <time_frame>4 weeks (after End Of Treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
          </group>
          <group group_id="O3">
            <title>24-wk Cirrhotic (CR) Treatment Group</title>
            <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
          </group>
        </group_list>
        <measure>
          <title>SVR24: Plasma HCV RNA Level &lt;25 IU/mL at 24 Weeks After EOT.</title>
          <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level &lt;25 IU/mL at 24 weeks after EOT.</description>
          <population>FAS</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="211"/>
                <count group_id="O2" value="213"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.0" lower_limit="75.8" upper_limit="86.3"/>
                    <measurement group_id="O2" value="74.2" lower_limit="68.3" upper_limit="80.1"/>
                    <measurement group_id="O3" value="72.2" lower_limit="61.9" upper_limit="82.6"/>
                  </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>Koch's stratum-adjusted Mantel Haenszel methods were used to compare durations, adjusting for stratification factors.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0447</p_value>
            <method>Koch´s method</method>
            <method_desc>Adjusted for PegIFN eligibility using Koch´s method, with continuity correction.</method_desc>
            <param_type>SVR24 Rates difference</param_type>
            <param_value>-6.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.8</ci_lower_limit>
            <ci_upper_limit>1.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prognostic Value of SVR12 Predicting SVR24</title>
        <description>The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.</description>
        <time_frame>24 Week (post-treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
            <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
          </group>
          <group group_id="O3">
            <title>24-wk Cirrhotic (CR) Treatment Group</title>
            <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
          </group>
        </group_list>
        <measure>
          <title>Prognostic Value of SVR12 Predicting SVR24</title>
          <description>The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.</description>
          <population>FAS</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="211"/>
                <count group_id="O2" value="213"/>
                <count group_id="O3" value="72"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0"/>
                    <measurement group_id="O2" value="99.0"/>
                    <measurement group_id="O3" value="98.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 28 days after all treatment discontinuation, upto 226 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>24-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.</description>
        </group>
        <group group_id="E2">
          <title>16-wk Non-cirrhotic (NC) Treatment Group</title>
          <description>Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.</description>
        </group>
        <group group_id="E3">
          <title>24-wk Cirrhotic (CR) Treatment Group</title>
          <description>24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 17.1</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="7" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Portal hypertensive gastropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute prerenal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 17.1</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="198" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="202" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="66" subjects_at_risk="72"/>
              </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="26" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular icterus</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="129" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="121" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="41" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="64" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </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="34" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="72"/>
              </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="14" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="72"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="211"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="72"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </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/NCT01728324
org study id: 1241.36
secondary id: 2012-003535-27
nct id: NCT01728324
lead sponsor: 
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI
      207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: SVR12 Rates With Historical Control
time frame: 12 Week (post-treatment)
description: Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint.
The number of participants analyzed are actually adjusted number of participant analyzed.
measure: Comparisons of SVR12 Rates Across Treatment Arms
time frame: 12 Week (post-treatment)
description: Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
measure: SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
time frame: 4 weeks (after End Of Treatment)
description: Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
measure: SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
time frame: 4 weeks (after End Of Treatment)
description: Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
measure: Prognostic Value of SVR12 Predicting SVR24
time frame: 24 Week (post-treatment)
description: The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
arm group label: Randomised 24-week arm
arm group type: Experimental
description: BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
arm group label: Randomised 16-week arm
arm group type: Experimental
description: BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
arm group label: Allocated 24-week arm
arm group type: Experimental
description: BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
intervention type: Drug
intervention name: BI 207127-placebo: 8-week treatment
description: 8 weeks of placebo treatment
arm group label: Randomised 16-week arm
intervention type: Drug
intervention name: Ribavirin: 24-week treatment
description: 24 weeks of active treatment
arm group label: Allocated 24-week arm
intervention type: Drug
intervention name: BI 207127: 24-week treatment
description: 24 weeks of active treatment
arm group label: Randomised 24-week arm
intervention type: Drug
intervention name: Faldaprevir: 24-week treatment
description: 24 weeks of active treatment
arm group label: Allocated 24-week arm
intervention type: Drug
intervention name: Faldaprevir: 24-week treatment
description: 24 weeks of active treatment
arm group label: Randomised 24-week arm
intervention type: Drug
intervention name: Ribavirin-placebo: 8-week treatment
description: 8 weeks of placebo treatment
arm group label: Randomised 16-week arm
intervention type: Drug
intervention name: BI 207127: 24-week treatment
description: 24 weeks of active treatment
arm group label: Allocated 24-week arm
intervention type: Drug
intervention name: Faldaprevir-placebo: 8-week treatment
description: 8 weeks of placebo treatment
arm group label: Randomised 16-week arm
intervention type: Drug
intervention name: Faldaprevir: 16-week treatment
description: 16 weeks of active treatment
arm group label: Randomised 16-week arm
intervention type: Drug
intervention name: Ribavirin: 16-week treatment
description: 16 weeks of active treatment
arm group label: Randomised 16-week arm
intervention type: Drug
intervention name: RBV: 24-week treatment
description: 24 weeks of active treatment
arm group label: Randomised 24-week arm
intervention type: Drug
intervention name: BI 207127: 16-week treatment
description: 16 weeks of active treatment
arm group label: Randomised 16-week arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Greece
country: Italy
country: New Zealand
country: Portugal
country: Spain
country: United Kingdom
country: United States
country: Korea, Republic of
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Ribavirin
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 