<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/NCT01718145</url>
  </required_header>
  <id_info>
    <org_study_id>AI447-031</org_study_id>
    <nct_id>NCT01718145</nct_id>
  </id_info>
  <brief_title>A Phase 3, Comparative Study of Asunaprevir and Daclatasvir Combination Therapy Versus Telaprevir Therapy in Japanese HCV Subjects</brief_title>
  <official_title>A Phase 3, Comparative Study of Asunaprevir and Daclatasvir (DUAL) Combination Therapy Versus Telaprevir Therapy in Japanese Genotype 1b Chronic Hepatitis C IFN Eligible-naive Subjects With a Single Arm Assessment of DUAL Therapy in IFN-therapy Relapsers</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 assess the anti-viral activity of BMS-790052 and BMS-650032&#xD;
      combination therapy in Japanese subject.&#xD;
&#xD;
      The purpose of this study is to compare the anti-viral activity of the co-administration of&#xD;
      Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese&#xD;
      Hepatitis C virus (HCV) subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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 SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort</measure>
    <time_frame>After 12 weeks of the last dose</time_frame>
    <description>SVR12 = Sustained virologic response at post-treatment Week 12&#xD;
LLOQ = Lower Limit of quantitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with hemoglobin &lt; 10g/dL</measure>
    <time_frame>First 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with rash-related dermatologic events</measure>
    <time_frame>First 12 weeks of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort</measure>
    <time_frame>At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24</time_frame>
    <description>EOT = End of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with HCV RNA target not detected in the naive cohort</measure>
    <time_frame>At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24</time_frame>
    <description>eRVR = Extended rapid virologic response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort</measure>
    <time_frame>At post-treatment Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort</measure>
    <time_frame>At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with HCV RNA target not detected in the relapser cohort</measure>
    <time_frame>At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group</measure>
    <time_frame>End of treatment (24 weeks) plus 7days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Hepatitis C Virus Infection</condition>
  <arm_group>
    <arm_group_label>Arm 1: Daclatasvir + Asunaprevir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks&#xD;
- Naive cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Telaprevir + pegIFNα-2b + Ribavirin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly &amp; Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks&#xD;
- Naive cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 3: Daclatasvir + Asunaprevir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks&#xD;
- Relapser cohort</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Daclatasvir</intervention_name>
    <arm_group_label>Arm 1: Daclatasvir + Asunaprevir</arm_group_label>
    <arm_group_label>Arm 3: Daclatasvir + Asunaprevir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Asunaprevir</intervention_name>
    <arm_group_label>Arm 1: Daclatasvir + Asunaprevir</arm_group_label>
    <arm_group_label>Arm 3: Daclatasvir + Asunaprevir</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>Arm 2: Telaprevir + pegIFNα-2b + Ribavirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>pegIFNα-2b</intervention_name>
    <arm_group_label>Arm 2: Telaprevir + pegIFNα-2b + Ribavirin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telaprevir</intervention_name>
    <arm_group_label>Arm 2: Telaprevir + pegIFNα-2b + Ribavirin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic HCV-1b infected patient&#xD;
&#xD;
          -  HCV Ribonucleic acid (RNA) &gt; 100,000 IU/mL at screening&#xD;
&#xD;
          -  Ages 20 to 70 years (for the Naive cohort), ages 20 to 75 years (for the Relapser&#xD;
             cohort)&#xD;
&#xD;
          -  Treatment naive subjects to Interferon (IFN) based therapy&#xD;
&#xD;
          -  Subjects who had undetectable HCV RNA at end of treatment with prior exposure to an&#xD;
             IFN-containing regimen, but HCV RNA detectable within 24 weeks of treatment follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have;&#xD;
&#xD;
               -  Hepatocellular carcinoma&#xD;
&#xD;
               -  Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)&#xD;
&#xD;
               -  Severe or uncontrollable complication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</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>Local Institution</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4668560</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Toyoake Shi</city>
        <state>Aichi</state>
        <zip>4701192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>2608677</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>8108563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <zip>8300011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Ogaki-shi</city>
        <state>Gifu</state>
        <zip>5038502</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Takasaki City</city>
        <state>Gunma</state>
        <zip>3700829</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>7340037</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Obihiro-shi</city>
        <state>Hokkaido</state>
        <zip>080-0016</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>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0608648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Takamatsu-shi</city>
        <state>Kagawa</state>
        <zip>760-8557</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima</state>
        <zip>8908520</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>2360004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto</state>
        <zip>8608556</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>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9808574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>3908621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nagasaki-shi</city>
        <state>Nagasaki</state>
        <zip>8528501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Omura</city>
        <state>Nagasaki</state>
        <zip>8568562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Kashihara</city>
        <state>Nara</state>
        <zip>6348522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yufu</city>
        <state>Oita</state>
        <zip>8795593</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>7008558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>5898511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>5438555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>5458586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>5650871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>5640013</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Iruma-gun</city>
        <state>Saitama</state>
        <zip>3500495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Izunokuni</city>
        <state>Shizuoka</state>
        <zip>4102295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Shimotsuke-shi</city>
        <state>Tochigi</state>
        <zip>3290498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138655</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>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>1428666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Yamagata-shi</city>
        <state>Yamagata</state>
        <zip>9909585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Chuo-shi</city>
        <state>Yamanashi</state>
        <zip>4093898</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fukui</city>
        <zip>9188503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fukuoka</city>
        <zip>8140180</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Fukuoka</city>
        <zip>8158555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Gifu</city>
        <zip>5008513</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>Nagoya-shi</city>
        <zip>4678602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nishinomiya-shi</city>
        <zip>6638501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Osaka</city>
        <zip>5400006</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Saitama</city>
        <zip>3380001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</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>Asunaprevir</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/NCT01718145
org study id: AI447-031
nct id: NCT01718145
lead sponsor: 
has dmc: No
The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032
      combination therapy in Japanese subject.

      The purpose of this study is to compare the anti-viral activity of the co-administration of
      Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy in Japanese
      Hepatitis C virus (HCV) subjects
Intervention Model: Parallel in the Naive cohort and Single group in the Relapser cohort
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the naive cohort
time frame: After 12 weeks of the last dose
description: SVR12 = Sustained virologic response at post-treatment Week 12
LLOQ = Lower Limit of quantitation
measure: Proportion of subjects with hemoglobin < 10g/dL
time frame: First 12 weeks of treatment
measure: Proportion of subjects with rash-related dermatologic events
time frame: First 12 weeks of treatment
measure: Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the naive cohort
time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and post-treatment Week 24
description: EOT = End of treatment
measure: Proportion of subjects with HCV RNA target not detected in the naive cohort
time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
description: eRVR = Extended rapid virologic response
measure: Proportion of subjects with SVR12, defined as HCV RNA target detected or target not detected below LLOQ in the relapser cohort
time frame: At post-treatment Week 12
measure: Proportion of subjects with HCV RNA target detected or target not detected below LLOQ in the relapser cohort
time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12; EOT (up to 24 weeks), post-treatment Week 4 and Week 24
measure: Proportion of subjects with HCV RNA target not detected in the relapser cohort
time frame: At weeks 1, 2, 4, 6, 8 and 12; at both Weeks 4 and 12 [eRVR]; EOT (up to 24 weeks), post-treatment Week 4, post-treatment Week 12 and post-treatment Week 24
measure: On treatment safety, as measured by the frequency of Severe adverse events (SAEs), discontinuation and dose modification/interruption due to Adverse events (AEs), Grade 3-4 abnormalities observed from clinical laboratory tests for each treatment group
time frame: End of treatment (24 weeks) plus 7days
arm group label: Arm 1: Daclatasvir + Asunaprevir
arm group type: Experimental
description: Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Naive cohort
arm group label: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
arm group type: Active Comparator
description: Telaprevir 750 mg tablets by mouth three times daily, pegIFNα-2b 1.5 μg/kg solution by Subcutaneous weekly & Ribavirin 600- 1000 mg Capsules by mouth twice daily for 24 Weeks
- Naive cohort
arm group label: Arm 3: Daclatasvir + Asunaprevir
arm group type: Experimental
description: Daclatasvir 60 mg tablets by mouth once daily and Asunaprevir 200 mg capsules by mouth twice daily for 24 weeks
- Relapser cohort
intervention type: Drug
intervention name: Daclatasvir
arm group label: Arm 1: Daclatasvir + Asunaprevir
arm group label: Arm 3: Daclatasvir + Asunaprevir
intervention type: Drug
intervention name: Asunaprevir
arm group label: Arm 1: Daclatasvir + Asunaprevir
arm group label: Arm 3: Daclatasvir + Asunaprevir
intervention type: Drug
intervention name: Ribavirin
arm group label: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
intervention type: Biological
intervention name: pegIFNα-2b
arm group label: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
intervention type: Drug
intervention name: Telaprevir
arm group label: Arm 2: Telaprevir + pegIFNα-2b + Ribavirin
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Japan
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: Asunaprevir