<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/NCT01718158</url>
  </required_header>
  <id_info>
    <org_study_id>AI452-021</org_study_id>
    <secondary_id>2011-005409-65</secondary_id>
    <nct_id>NCT01718158</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy</brief_title>
  <acronym>STRUCTURE</acronym>
  <official_title>A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,&#xD;
      given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as&#xD;
      the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects&#xD;
      who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior&#xD;
      anti-HCV treatment, or who have relapsed after an initial, successful treatment with&#xD;
      Pegylated Interferon Alfa + Ribavirin&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)</measure>
    <time_frame>Post treatment follow-up Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve SVR12 in treatment-naive subjects</measure>
    <time_frame>Post treatment follow-up Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with rash related dermatologic events</measure>
    <time_frame>Up to 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who develop treatment emergent cytopenic abnormalities</measure>
    <time_frame>Up to 48 Weeks</time_frame>
    <description>Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) &lt; 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) &lt; 750/mm3, and or thrombocytopenia as defined by platelets &lt; 50,000/mm3]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms</measure>
    <time_frame>Up to 48 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) &lt; Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24</measure>
    <time_frame>Post treatment follow-up Week 24</time_frame>
    <description>SVR24 = Sustained virologic response at post treatment follow-up Week 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up</measure>
    <time_frame>Maximum of 72 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve SVR12 with a 24-week treatment regimen</measure>
    <time_frame>Post treatment follow-up Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA &lt; LLOQ target not detected at Weeks 4 and 12 of treatment)</measure>
    <time_frame>Weeks 4 and 12 of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up</measure>
    <time_frame>Maximum of 72 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)</measure>
    <time_frame>Maximum of 72 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT</measure>
    <time_frame>Maximum of 48 weeks</time_frame>
    <description>Psychiatric symptoms (depression, irritability or insomnia)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses</measure>
    <time_frame>Post-treatment follow-up Week 12</time_frame>
    <description>For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resistant variants associated with virologic failure through end of follow-up</measure>
    <time_frame>Maximum of 72 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">444</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Peginterferon Lambda-1a + Ribavirin + Daclatasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks&#xD;
Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects &lt; 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 weeks&#xD;
Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peginterferon Alfa-2a + Ribavirin + Telaprevir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response&#xD;
Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects &lt; 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 to 48 weeks depending on response&#xD;
Telaprevir 375 mg tablets [2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Peginterferon Lambda-1a</intervention_name>
    <arm_group_label>Peginterferon Lambda-1a + Ribavirin + Daclatasvir</arm_group_label>
    <other_name>BMS-914143</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Peginterferon Alfa-2a</intervention_name>
    <arm_group_label>Peginterferon Alfa-2a + Ribavirin + Telaprevir</arm_group_label>
    <other_name>Pegasys®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>Peginterferon Alfa-2a + Ribavirin + Telaprevir</arm_group_label>
    <arm_group_label>Peginterferon Lambda-1a + Ribavirin + Daclatasvir</arm_group_label>
    <other_name>Copegus®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir</intervention_name>
    <arm_group_label>Peginterferon Lambda-1a + Ribavirin + Daclatasvir</arm_group_label>
    <other_name>BMS-790052</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telaprevir</intervention_name>
    <arm_group_label>Peginterferon Alfa-2a + Ribavirin + Telaprevir</arm_group_label>
    <other_name>Incivek®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients chronically infected with HCV Genotype-1b&#xD;
&#xD;
          -  Naïve to prior treatment or documented evidence of relapse after completion of the&#xD;
             prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined&#xD;
             based upon local guidelines)&#xD;
&#xD;
          -  HCV RNA viral load ≥100,000 IU/mL at screening&#xD;
&#xD;
          -  Patients with compensated cirrhosis are permitted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection with Hepatitis C virus (HCV) other than Genotype-1b&#xD;
&#xD;
          -  Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus&#xD;
             (HIV)-1/HIV-2 antibody test at screening&#xD;
&#xD;
          -  Evidence of chronic liver disease caused by diseases other than chronic HCV infection&#xD;
&#xD;
          -  Current evidence of or history of variceal bleeding, hepatic encephalopathy, or&#xD;
             ascites requiring diuretics or paracentesis or evidence of any of these findings on&#xD;
             physical examination performed at screening&#xD;
&#xD;
          -  Current or known history of cancer (except adequately treated in situ carcinoma of the&#xD;
             cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to&#xD;
             screening&#xD;
&#xD;
          -  Current evidence or known history of decompensated cirrhosis based on radiologic&#xD;
             criteria or biopsy results and clinical criteria&#xD;
&#xD;
          -  Laboratory values:&#xD;
&#xD;
               1. Hemoglobin &lt;12.0 g/dL (males) or &lt;11.0 g/dL (females)&#xD;
&#xD;
               2. Platelets &lt;90,000/mm3&#xD;
&#xD;
               3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Va Long Beach Healthcare System</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastrointestinal Specialists Of Georgia Pc</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Group Of The Hudson Valley, Pc</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nashville Medical Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Clinical Research Institute, Llc</name>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <zip>76012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medvamc</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>C1405BCK</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mar Del Plata</city>
        <state>Buenos Aires</state>
        <zip>B7600FZN</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Prov De Santa Fe</city>
        <state>Santa Fe</state>
        <zip>2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1119</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1221</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1181</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94804</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hamburg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Haifa</city>
        <zip>34362</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tel-Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zafed</city>
        <zip>13110</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Foggia</city>
        <zip>71100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Messina</city>
        <zip>98125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Pisa</city>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4678602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka</state>
        <zip>8028533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <zip>8030816</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>7348511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0600033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>6500047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Higashiibaraki-gun</city>
        <state>Ibaraki</state>
        <zip>3313193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kawasaki-shi</city>
        <state>Kanagawa</state>
        <zip>2138587</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>2458575</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>2320024</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>6028566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>6128555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <zip>1058470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Musashino-shi</city>
        <state>Tokyo</state>
        <zip>1808610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Sumida-ku</city>
        <state>Tokyo</state>
        <zip>1308575</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tanabe-shi</city>
        <state>Wakayama</state>
        <zip>6468558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gifu</city>
        <zip>5008727</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kumamoto</city>
        <zip>8628655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Saga</city>
        <zip>8408571</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Busan</city>
        <zip>614-735</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>110-774</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>135-720</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>138-736</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Seoul</city>
        <zip>143-729</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bialystok</city>
        <zip>15-540</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lodz</city>
        <zip>91-347</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Myslowice</city>
        <zip>41-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-349</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>111123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>119992</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>121170</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Moscow</city>
        <zip>125367</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St. Petersburg</city>
        <zip>191167</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St. Petersburg</city>
        <zip>196645</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Stavropol</city>
        <zip>355017</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80756</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Tainan</city>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS clinical trial educational resource</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <disposition_first_submitted>September 23, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>September 23, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 9, 2015</disposition_first_posted>
  <last_update_submitted>September 23, 2015</last_update_submitted>
  <last_update_submitted_qc>September 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2015</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</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01718158
org study id: AI452-021
secondary id: 2011-005409-65
nct id: NCT01718158
lead sponsor: 
has dmc: No
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,
      given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as
      the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects
      who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior
      anti-HCV treatment, or who have relapsed after an initial, successful treatment with
      Pegylated Interferon Alfa + Ribavirin
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)
time frame: Post treatment follow-up Week 12
measure: Proportion of subjects who achieve SVR12 in treatment-naive subjects
time frame: Post treatment follow-up Week 12
measure: Proportion of subjects with rash related dermatologic events
time frame: Up to 12 weeks of treatment
measure: Proportion of subjects who develop treatment emergent cytopenic abnormalities
time frame: Up to 48 Weeks
description: Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3]
measure: Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms
time frame: Up to 48 Weeks
measure: Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24
time frame: Post treatment follow-up Week 24
description: SVR24 = Sustained virologic response at post treatment follow-up Week 24
measure: Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up
time frame: Maximum of 72 weeks
measure: Proportion of subjects who achieve SVR12 with a 24-week treatment regimen
time frame: Post treatment follow-up Week 12
measure: Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment)
time frame: Weeks 4 and 12 of treatment
measure: Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up
time frame: Maximum of 72 weeks
measure: Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)
time frame: Maximum of 72 weeks
measure: Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT
time frame: Maximum of 48 weeks
description: Psychiatric symptoms (depression, irritability or insomnia)
measure: Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses
time frame: Post-treatment follow-up Week 12
description: For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen
measure: Resistant variants associated with virologic failure through end of follow-up
time frame: Maximum of 72 weeks
arm group label: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
arm group type: Experimental
description: Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks
Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 weeks
Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks
arm group label: Peginterferon Alfa-2a + Ribavirin + Telaprevir
arm group type: Experimental
description: Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response
Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 to 48 weeks depending on response
Telaprevir 375 mg tablets [2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks
intervention type: Biological
intervention name: Peginterferon Lambda-1a
arm group label: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
other name: BMS-914143
intervention type: Biological
intervention name: Peginterferon Alfa-2a
arm group label: Peginterferon Alfa-2a + Ribavirin + Telaprevir
other name: Pegasys®
intervention type: Drug
intervention name: Ribavirin
arm group label: Peginterferon Alfa-2a + Ribavirin + Telaprevir
arm group label: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
other name: Copegus®
intervention type: Drug
intervention name: Daclatasvir
arm group label: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
other name: BMS-790052
intervention type: Drug
intervention name: Telaprevir
arm group label: Peginterferon Alfa-2a + Ribavirin + Telaprevir
other name: Incivek®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: France
country: Germany
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: United Kingdom
country: United States
url: http://www.bms.com/studyconnect/Pages/home.aspx
description: BMS clinical trial educational resource
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Ribavirin
mesh term: Peginterferon alfa-2a