<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/NCT01721265</url>
  </required_header>
  <id_info>
    <org_study_id>1894-009</org_study_id>
    <secondary_id>IDX-03YF</secondary_id>
    <nct_id>NCT01721265</nct_id>
  </id_info>
  <brief_title>3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals</brief_title>
  <official_title>3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Merck Sharp &amp; Dohme LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      All subjects in this study have previously been in an Idenix HCV study and received study&#xD;
      drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study&#xD;
      will not be enrolled in this study.&#xD;
&#xD;
      In this study, researchers will try to find answers to these questions:&#xD;
&#xD;
        -  How much (if any) hepatitis C virus is in your blood after stopping your Idenix study&#xD;
           drug?&#xD;
&#xD;
        -  Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or&#xD;
           similar drugs?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The data obtained from this study will be used to further understand the long-term efficacy&#xD;
      of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix&#xD;
      DAAs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Durability of Sustained viral response [SVR]</measure>
    <time_frame>every 3 months</time_frame>
    <description>To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Kinetics of resistant variants</measure>
    <time_frame>every 3 months</time_frame>
    <description>To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.</description>
  </secondary_outcome>
  <enrollment type="Actual">145</enrollment>
  <condition>Hepatitis C</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population will include subjects who participated in studies of Idenix anti-HCV DAAs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Read and signed the written informed consent form (ICF) after the nature of the study&#xD;
             has been fully explained&#xD;
&#xD;
          -  Have participated in an Idenix-sponsored study of an Idenix DAA&#xD;
&#xD;
          -  Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study&#xD;
&#xD;
          -  Agreed to comply with the visit schedule and laboratory tests&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with placebo only, in an Idenix sponsored study&#xD;
&#xD;
          -  Antiviral treatment for HCV after participation in an Idenix sponsored study of an&#xD;
             Idenix DAA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 31, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>April 15, 2015</last_update_submitted>
  <last_update_submitted_qc>April 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <keyword>Hepatitis C</keyword>
  <keyword>IDX184</keyword>
  <keyword>IDX719</keyword>
  <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>
  <!-- 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/NCT01721265
org study id: 1894-009
secondary id: IDX-03YF
nct id: NCT01721265
lead sponsor: 
has dmc: No
All subjects in this study have previously been in an Idenix HCV study and received study
      drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study
      will not be enrolled in this study.

      In this study, researchers will try to find answers to these questions:

        -  How much (if any) hepatitis C virus is in your blood after stopping your Idenix study
           drug?

        -  Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or
           similar drugs?
The data obtained from this study will be used to further understand the long-term efficacy
      of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix
      DAAs.
observational model: Cohort
time perspective: Prospective
measure: Durability of Sustained viral response [SVR]
time frame: every 3 months
description: To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.
measure: Kinetics of resistant variants
time frame: every 3 months
description: To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.
Human plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
country: United States
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis