<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/NCT02250001</url>
  </required_header>
  <id_info>
    <org_study_id>AI444-244</org_study_id>
    <nct_id>NCT02250001</nct_id>
  </id_info>
  <brief_title>Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C</brief_title>
  <official_title>Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C</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 primary objective of this study is: To evaluate the real-world safety, specifically the&#xD;
      incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in&#xD;
      Japanese patients chronically infected with HCV GT-1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Time Perspective: Other - For patients who are treated before the contract between&#xD;
      Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data&#xD;
      will be collected retrospectively after the contract is signed. Data will be collected&#xD;
      prospectively for patients who initiate DCV/ASV treatment after the contract is initiated&#xD;
&#xD;
      Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">January 20, 2017</completion_date>
  <primary_completion_date type="Actual">January 20, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>48 Weeks</target_duration>
  <primary_outcome>
    <measure>The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)</measure>
    <time_frame>28 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)</measure>
    <time_frame>48 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2974</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Treatment with DCV/ASV</arm_group_label>
    <description>Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        University hospitals, General hospitals, and clinics that have relevant departments, such&#xD;
        as Liver Internal medicine, Gastroenterological medicine, Internal medicine, etc, where the&#xD;
        surveillance drug is mainly prescribed&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are initiating DCV and ASV treatment for the first time under the&#xD;
             approved indications, dosage, and administration will be included in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 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>Local Institution</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0033</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02250001
org study id: AI444-244
nct id: NCT02250001
lead sponsor: 
has dmc: No
The primary objective of this study is: To evaluate the real-world safety, specifically the
      incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in
      Japanese patients chronically infected with HCV GT-1.
Time Perspective: Other - For patients who are treated before the contract between
      Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data
      will be collected retrospectively after the contract is signed. Data will be collected
      prospectively for patients who initiate DCV/ASV treatment after the contract is initiated

      Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)
observational model: Case-Only
time perspective: Other
measure: The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)
time frame: 28 weeks
measure: Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)
time frame: 48 weeks
arm group label: Treatment with DCV/ASV
description: Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic