<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/NCT01732796</url>
  </required_header>
  <id_info>
    <org_study_id>1241.20</org_study_id>
    <secondary_id>2012-003533-41</secondary_id>
    <nct_id>NCT01732796</nct_id>
  </id_info>
  <brief_title>IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1</brief_title>
  <official_title>A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection</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 of treatment for 16 and 24 weeks in chronically&#xD;
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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 ribonucleic acid (HCV RNA) level &lt;25 international units/millilitre (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</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</measure>
    <time_frame>4 Week (post-treatment)</time_frame>
    <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SVR24</measure>
    <time_frame>24 Week (post-treatment)</time_frame>
    <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">470</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Allocated 24 weeks BI 207127 + BI 201335</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 weeks of BI 207127 and BI 201335 in combination with Ribavirin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized 16 weeks BI 7127+BI1335 + RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized 24weeks BI 7127+ BI1335 + RBV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 weeks of BI 207127and BI 201335 in combination with RBV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>24 weeks of active RBV</description>
    <arm_group_label>Allocated 24 weeks BI 207127 + BI 201335</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 (Faldaprevir)</intervention_name>
    <description>16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335</description>
    <arm_group_label>Randomized 16 weeks BI 7127+BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>24 weeks of active RBV</description>
    <arm_group_label>Randomized 24weeks BI 7127+ BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127</intervention_name>
    <description>24 weeks of BI 207127</description>
    <arm_group_label>Randomized 24weeks BI 7127+ BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 201335 (Faldaprevir)</intervention_name>
    <description>24 weeks of BI 201335</description>
    <arm_group_label>Allocated 24 weeks BI 207127 + BI 201335</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin (RBV)</intervention_name>
    <description>16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin</description>
    <arm_group_label>Randomized 16 weeks BI 7127+BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127</intervention_name>
    <description>16 weeks BI 207127 followed by 8 weeks placebo to BI 207127</description>
    <arm_group_label>Randomized 16 weeks BI 7127+BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Faldaprevir (BI 201335)</intervention_name>
    <description>24 weeks of 201335</description>
    <arm_group_label>Randomized 24weeks BI 7127+ BI1335 + RBV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 207127</intervention_name>
    <description>24 weeks of BI 207127</description>
    <arm_group_label>Allocated 24 weeks BI 207127 + BI 201335</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Chronic hepatitis C infection, diagnosed by positive HCV Ab or detectable HCV RNA at&#xD;
             screening in addition to at least one of the following:&#xD;
&#xD;
               1. positive HCV RNA or HCV antibodies at least 6 months prior to screening, or&#xD;
&#xD;
               2. liver biopsy typical of chronic hepatitis C , or&#xD;
&#xD;
               3. history of elevated ALT at least 6 months prior to screening.&#xD;
&#xD;
          -  HCV infection of sub-GT1b confirmed by genotypic testing at screening&#xD;
&#xD;
          -  Treatment naïve defined as:&#xD;
&#xD;
               1. no prior treatment with any interferon, pegylated interferon, and /or ribavirin&#xD;
                  and&#xD;
&#xD;
               2. no prior treatment with at least one dose of any other licensed or&#xD;
                  investigational antiviral agent for acute or chronic hepatitis C infection&#xD;
&#xD;
          -  Plasma HCV RNA &gt; or = 1,000 IU/mL at screening&#xD;
&#xD;
          -  Liver biopsy within three years or fibroscan within six months prior to randomization.&#xD;
             Patients with compensated liver cirrhosis (score Child-Pugh A) could also be included.&#xD;
&#xD;
          -  Age 18 to 75 years&#xD;
&#xD;
          -  Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to&#xD;
             randomization&#xD;
&#xD;
               1. with documented hysterectomy, or&#xD;
&#xD;
               2. who have had both ovaries removed, or&#xD;
&#xD;
               3. with documented tubal ligation, or&#xD;
&#xD;
               4. who are post-menopausal with last menstrual period at least 12 months prior to&#xD;
                  screening, or&#xD;
&#xD;
               5. of childbearing potential with a negative serum pregnancy test at screening and a&#xD;
                  negative urine pregnancy test on Day 1 (Visit 2), that agree to use two&#xD;
                  non-hormonal methods of birth control from the date of screening until months&#xD;
                  after the last dose of ribavirin. They must not breast-feed at any time from the&#xD;
                  date of screening until 7 months after the last dose of ribavirin. Medically&#xD;
                  accepted methods of contraception for females in this trial are diaphragm with&#xD;
                  spermicide substance, intrauterine devices, cervical caps and condoms.&#xD;
&#xD;
        OR:&#xD;
&#xD;
        Male patients&#xD;
&#xD;
          1. who are documented to be sterile, or&#xD;
&#xD;
          2. who consistently and correctly use a condom while their female partners (if of&#xD;
             child-bearing potential) agree to use one of the appropriate medically accepted&#xD;
             methods of birth control from the date of screening until 7 months after the last dose&#xD;
             of ribavirin, and&#xD;
&#xD;
          3. without pregnant female partners. It is in the responsibility of the male patient to&#xD;
             ensure that his partner (or partners) is not pregnant prior to enrolment into the&#xD;
             study or becomes pregnant during the treatment and follow-up phase. Female partners of&#xD;
             childbearing potential must perform monthly pregnancy tests from the date of screening&#xD;
             until 7 months after the last dose of ribavirin (tests will be provided by the&#xD;
             sponsor).&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at&#xD;
             screening.&#xD;
&#xD;
          -  HCV subtype 1a, mixed 1a/1b or GT1 undefined&#xD;
&#xD;
          -  Evidence of liver disease mainly due to causes other than chronic HCV infection such&#xD;
             as autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's&#xD;
             disease&#xD;
&#xD;
          -  HIV-1 or HIV-2 infection&#xD;
&#xD;
          -  Hepatitis B virus (HBV) infection based on presence of HBs-Ag&#xD;
&#xD;
          -  Evidence of decompensated liver disease, or history of decompensated liver disease,&#xD;
             defined as history of ascites, hepatic encephalopathy, or bleeding esophageal varices,&#xD;
&#xD;
          -  International Normalized Ratio (INR) &gt; or =1.7&#xD;
&#xD;
          -  Serum albumin &lt; 3.3 g/dL&#xD;
&#xD;
          -  Serum total bilirubin &gt;2.0 times the upper limit of normal (ULN) with direct/indirect&#xD;
             ratio &gt;1, unless history of Gilbert's disease&#xD;
&#xD;
          -  Active or suspected malignancy or history of malignancy within the last 5 years (with&#xD;
             the exception of appropriately treated basal cell carcinoma of the skin or in situ&#xD;
             carcinoma of the uterine cervix)&#xD;
&#xD;
          -  Patients with ongoing or historical photosensitivity or recurrent rash&#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>1241.20.00026 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00033 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oceanside</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Poway</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00015 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fort Pierce</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Maitland</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00018 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00032 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00016 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00031 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00019 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00024 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00017 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00022 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.00020 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.43003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Graz</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Victoria</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Whitby</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.01007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Clermont-Ferrand Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Marseille Cedex 08</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Montpellier Cedex 5</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nice Cedex 3</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Pessac Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Rennes Cedex 09</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.33008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vandoeuvre Cedex</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49012 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Frankfurt am Main</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49014 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49009 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Herne</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49013 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49011 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Magdeburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49010 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Oberhausen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ulm</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.49007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Würzburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.36001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.36002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Kaposvar</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35303 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dublin 8</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35301 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35302 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Ancona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Brescia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Napoli</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.39004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.31001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>1241.20.31003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.31004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.31006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.31005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35103 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Aveiro</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35104 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Coimbra</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35101 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35102 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.35105 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Vila Real</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.40001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.40002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.40003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.70002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Chelyabinsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.70001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.70004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.70005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>A Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Alicante</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Majadahonda, Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34008 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Santander</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.34006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44005 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44007 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44001 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44002 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44006 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44004 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>1241.20.44003 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Switzerland</country>
  </removed_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related links</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <results_first_submitted>January 21, 2016</results_first_submitted>
  <results_first_submitted_qc>March 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 18, 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 27, 2014</disposition_first_posted>
  <last_update_submitted>March 17, 2016</last_update_submitted>
  <last_update_submitted_qc>March 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 18, 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 C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>It was planned that approximately 800 patients would be screened in order to randomize and treat approximately 460 patients (195 patients in treatment Groups 1 and 2 each, 40-70 patients in treatment Group 3).</recruitment_details>
      <pre_assignment_details>Treatment-naïve patients with chronic hepatitis C infection of genotype (GT)1b were included in the trial. Patients with compensated liver cirrhosis, defined as Ishak Grade ≥5 or METAVIR Grade ≥4 on liver biopsy, or liver stiffness of ≥ 13 kilopascal (kPa) on fibroscan, were assigned to Group 3.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>16 wk NC FDV+DBV+RBV</title>
          <description>600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).&#xD;
This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="P2">
          <title>24 wk NC FDV+DBV+RBV</title>
          <description>600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).&#xD;
This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="P3">
          <title>24 wk CR FDV+DBV+RBV</title>
          <description>600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="208"/>
                <participants group_id="P2" count="211"/>
                <participants group_id="P3" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="169"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="42"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <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="21"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason not defined above</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline characteristics were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).</population>
      <group_list>
        <group group_id="B1">
          <title>16 wk NC FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).&#xD;
This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="B2">
          <title>24 wk NC FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="B3">
          <title>24 wk CR FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</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="208"/>
            <count group_id="B2" value="211"/>
            <count group_id="B3" value="51"/>
            <count group_id="B4" value="470"/>
          </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="50.1" spread="12.7"/>
                    <measurement group_id="B2" value="51.1" spread="12.9"/>
                    <measurement group_id="B3" value="57.9" spread="8.8"/>
                    <measurement group_id="B4" value="51.4" spread="12.6"/>
                  </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="122"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="254"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="216"/>
                  </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 ribonucleic acid (HCV RNA) level &lt;25 international units/millilitre (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</description>
        <time_frame>12 Week (post-treatment)</time_frame>
        <population>The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (FAS).</population>
        <group_list>
          <group group_id="O1">
            <title>24 wk FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.</description>
          </group>
          <group group_id="O2">
            <title>16 wk FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.</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 ribonucleic acid (HCV RNA) level &lt;25 international units/millilitre (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</description>
          <population>The primary analyses of efficacy were carried out on an intent-to-treat basis including all randomized patients who were dispensed study medication and were documented to have taken at least one dose of study medication (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="262"/>
                <count group_id="O2" value="259"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>non-cirrhotic (N=174, 149)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.5"/>
                    <measurement group_id="O2" value="71.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>cirrhotic (N=37, 37)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.5"/>
                    <measurement group_id="O2" value="72.5"/>
                  </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 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Stratified one sample z-test</method>
            <param_type>Adjusted response rate</param_type>
            <param_value>81.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>76.6</ci_lower_limit>
            <ci_upper_limit>86.2</ci_upper_limit>
            <estimate_desc>Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The proportion of patients achieving SVR12 was compared to an acceptable minimum SVR rate achieved with an approved direct acting anti-viral (DAA) in combination with pegylated interferon-alfa (PegIFN) from historical data. The acceptable minimum SVR rate was 71% (reference for PegIFN-eligible).</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.3989</p_value>
            <method>Stratified one sample z-test</method>
            <param_type>Adjusted response rate</param_type>
            <param_value>71.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>66.1</ci_lower_limit>
            <ci_upper_limit>77.4</ci_upper_limit>
            <estimate_desc>Adjusted response rate will tested against 71%. It is calculated as a weighted average (non-cirrhotic: 89% times response rate+ cirrhotic: 11% times response rate), 11% is the highest rate of cirrhotic from historical trials with approved DAA+PegIFN</estimate_desc>
          </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>16 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O2">
            <title>24 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O3">
            <title>24 wk CR FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</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>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.6"/>
                    <measurement group_id="O2" value="82.5"/>
                    <measurement group_id="O3" value="72.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0040</p_value>
            <method>z-test</method>
            <method_desc>based on two sample z-test with continuity correction for variance.</method_desc>
            <param_type>Koch's method with continuity correction</param_type>
            <param_value>10.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.8</ci_lower_limit>
            <ci_upper_limit>18.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SVR4</title>
        <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).</description>
        <time_frame>4 Week (post-treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>16 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O2">
            <title>24 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O3">
            <title>24 wk CR FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>SVR4</title>
          <description>Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).</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="208"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of patients with response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.4"/>
                    <measurement group_id="O2" value="84.4"/>
                    <measurement group_id="O3" value="76.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive predicted value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.0"/>
                    <measurement group_id="O2" value="98.0"/>
                    <measurement group_id="O3" value="95.0"/>
                  </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>Category: Percentage of patient with response</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0575</p_value>
            <method>z-test</method>
            <method_desc>based on two sample z-test with continuity correction for variance.</method_desc>
            <param_type>Koch's method with continuity correction</param_type>
            <param_value>6.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>13.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SVR24</title>
        <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).</description>
        <time_frame>24 Week (post-treatment)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>16 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O2">
            <title>24 wk NC FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
          </group>
          <group group_id="O3">
            <title>24 wk CR FDV+DBV+RBV</title>
            <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>SVR24</title>
          <description>Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).</description>
          <population>FAS</population>
          <units>Percantage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="211"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of patients with response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7"/>
                    <measurement group_id="O2" value="80.6"/>
                    <measurement group_id="O3" value="72.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive predicted value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.0"/>
                    <measurement group_id="O2" value="99.0"/>
                    <measurement group_id="O3" value="100.0"/>
                  </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>Category: Percentage of patient with response</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0089</p_value>
            <method>z-test</method>
            <method_desc>based on two sample z-test with continuity correction for variance.</method_desc>
            <param_type>Koch's method with continuity correction</param_type>
            <param_value>9.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.7</ci_lower_limit>
            <ci_upper_limit>18.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first administration of study medication to 4 weeks after last intake (up to 200 days). Adverse events with an onset date thereafter were to be reported only if serious up to 24 or 48 weeks after last study treatment (up to 340 or 508 days).</time_frame>
      <desc>Safety analyses were based on the safety set that included all patients who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment, regardless of randomization.</desc>
      <group_list>
        <group group_id="E1">
          <title>16 wk NC FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).&#xD;
This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="E2">
          <title>24 wk NC FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).</description>
        </group>
        <group group_id="E3">
          <title>24 wk CR FDV+DBV+RBV</title>
          <description>600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.</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="208"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Agranulocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </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="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gastritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Dumping syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </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="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Psychotic disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Prerenal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="51"/>
              </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="192" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="198" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="49" subjects_at_risk="51"/>
              </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="40" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular icterus</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="66" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="112" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </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="9" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="51"/>
              </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="20" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="51"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
              </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="13" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="51"/>
              </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="18" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="208"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="211"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="51"/>
              </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>
    <limitations_and_caveats>BI stopped the further development of DBV, per protocol amendment the Follow-up period was reduced to 24 weeks for patients who achieved SVR12, and to 48 weeks for SVR12 non-responders provided they had not started an alternative HCV treatment.</limitations_and_caveats>
    <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/NCT01732796
org study id: 1241.20
secondary id: 2012-003533-41
nct id: NCT01732796
lead sponsor: 
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in 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 ribonucleic acid (HCV RNA) level <25 international units/millilitre (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
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
time frame: 4 Week (post-treatment)
description: Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4).
measure: SVR24
time frame: 24 Week (post-treatment)
description: Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24).
arm group label: Allocated 24 weeks BI 207127 + BI 201335
arm group type: Experimental
description: 24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
arm group label: Randomized 16 weeks BI 7127+BI1335 + RBV
arm group type: Experimental
description: 16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
arm group label: Randomized 24weeks BI 7127+ BI1335 + RBV
arm group type: Experimental
description: 24 weeks of BI 207127and BI 201335 in combination with RBV
intervention type: Drug
intervention name: Ribavirin (RBV)
description: 24 weeks of active RBV
arm group label: Allocated 24 weeks BI 207127 + BI 201335
intervention type: Drug
intervention name: BI 201335 (Faldaprevir)
description: 16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
arm group label: Randomized 16 weeks BI 7127+BI1335 + RBV
intervention type: Drug
intervention name: Ribavirin (RBV)
description: 24 weeks of active RBV
arm group label: Randomized 24weeks BI 7127+ BI1335 + RBV
intervention type: Drug
intervention name: BI 207127
description: 24 weeks of BI 207127
arm group label: Randomized 24weeks BI 7127+ BI1335 + RBV
intervention type: Drug
intervention name: BI 201335 (Faldaprevir)
description: 24 weeks of BI 201335
arm group label: Allocated 24 weeks BI 207127 + BI 201335
intervention type: Drug
intervention name: Ribavirin (RBV)
description: 16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
arm group label: Randomized 16 weeks BI 7127+BI1335 + RBV
intervention type: Drug
intervention name: BI 207127
description: 16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
arm group label: Randomized 16 weeks BI 7127+BI1335 + RBV
intervention type: Drug
intervention name: Faldaprevir (BI 201335)
description: 24 weeks of 201335
arm group label: Randomized 24weeks BI 7127+ BI1335 + RBV
intervention type: Drug
intervention name: BI 207127
description: 24 weeks of BI 207127
arm group label: Allocated 24 weeks BI 207127 + BI 201335
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: Austria
country: Canada
country: France
country: Germany
country: Hungary
country: Ireland
country: Italy
country: Netherlands
country: Portugal
country: Romania
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
country: Argentina
country: Brazil
country: Korea, Republic of
country: Mexico
country: Switzerland
url: http://trials.boehringer-ingelheim.com/
description: Related links
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: BI stopped the further development of DBV, per protocol amendment the Follow-up period was reduced to 24 weeks for patients who achieved SVR12, and to 48 weeks for SVR12 non-responders provided they had not started an alternative HCV treatment.
point of contact: 