<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/NCT01716403</url>
  </required_header>
  <id_info>
    <org_study_id>1211</org_study_id>
    <nct_id>NCT01716403</nct_id>
  </id_info>
  <brief_title>Telaprevir Exposure and Severe Anemia in HCV Infected Patients Treated by Tri-therapy</brief_title>
  <acronym>Ribatela</acronym>
  <official_title>Influence of Telaprevir Exposure on the Severe Anemia Induced by Ribavirin/Pegylated Interferon/Telaprevir Tri-therapy in HCV Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The risk of severe anemia is increased in patients treated by tri-therapy compared to&#xD;
      patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain&#xD;
      unexplored but could also depend on the global exposure of telaprevir. The trough&#xD;
      concentration or AUC of telaprevir could therefore be a predictive factor of the onset of&#xD;
      anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of&#xD;
      telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve&#xD;
      tolerance and SVR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>October 2012</start_date>
  <primary_completion_date type="Actual">October 2014</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>telaprevir concentration and area under the curve</measure>
    <time_frame>Day 0, Day 2, week 2, week 4, week 8 and week12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ribavirin concentration and area under the curve</measure>
    <time_frame>Day 0, Day 2, week 2, week 4, week 8 and week12</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>viral load</measure>
    <time_frame>Day 0</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>C Hepatitis, Tri Therapy</condition>
  <arm_group>
    <arm_group_label>HCV tritherapy and anemia</arm_group_label>
    <description>HCV-genotype 1 infected patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition</intervention_name>
    <arm_group_label>HCV tritherapy and anemia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        48 HCV-genotype 1 infected patients (16 naive patients, 16 prior partial&#xD;
        responders/relapsers and 16 prior null responders to ribavirin/PEG-INF treatment)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman older than 18 yr. 2- HCV genotype 1 infection as confirmed by a positive&#xD;
             viral load 6 months after the selection visit or confirmed by the mean of a liver&#xD;
             biopsy within 1 year before screening for the study.&#xD;
&#xD;
             3- Patient with one of the following criteria: Patient naive of any treatment against&#xD;
             HCV infection Or Prior null responder patient: patient previously treated by&#xD;
             ribavirin/PEG-INF for at least 12 weeks and whom HCV viral load decline was &lt;2 log at&#xD;
             week 12 Or Prior partial responder patient: patient previously treated by&#xD;
             ribavirin/PEG-INF for at least 12 weeks, who never had a negative viral load while the&#xD;
             viral load decline was &gt;2 log at week 12 Or Prior relapser patient: patient previously&#xD;
             treated by ribavirin/PEG-INF for 48 weeks, with a negative viral load at the end of&#xD;
             treatment and a positive viral load 6 months later 4- Patient who has stopped his&#xD;
             treatment for at least 12 weeks 5- Patient who had a liver biopsy or a Fibroscan&#xD;
             within the 24 months before the start of the study with a Metavir fibrosis score F ≥&#xD;
             3.&#xD;
&#xD;
             6- Patient who fulfills criteria for telaprevir treatment as defined by the licence 7-&#xD;
             Patients who accepts to use 2 contraceptive methods until 6 months after the end of&#xD;
             the treatment 8- Patient who had given his written informed consent 10- Patient&#xD;
             insured under the french social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1- Infection/co-infection by HCV genotype different than genotype 1 2- Patient with a&#xD;
        medical contraindication to PEG-INF or ribavirin 3- Patient with history of allergy or&#xD;
        intolerance to telaprevir 4- Patient using contraindicated drugs 5- Patient with history of&#xD;
        decompensated liver disease and/or presenting biochemical measurements as follows at the&#xD;
        inclusion visit:&#xD;
&#xD;
          -  International Normalized Ratio (INR) &gt; 1,5&#xD;
&#xD;
          -  Albumin &lt;3,3 g/dl&#xD;
&#xD;
          -  Total bilirubin&gt;1,8 N apart for patient with Gilbert syndrome 6- Liver disease from&#xD;
             other causes 7- Patient with hepatocellular carcinoma or history of cancer 8- Patient&#xD;
             with a history of graft transplantation and treated by immunosuppressive drugs 9-&#xD;
             Patient who are regularly treated by corticosteroids 11- Patient with hemophilia or&#xD;
             coagulation troubles 12- HIV or HBV co-infection 14- Patient with body mass index&gt; 30&#xD;
             kg/m2.&#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>Jean-Pierre Zarski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grenoble University Hospital</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>C hepatitis, telaprevir concentration, ribavirin oncentration, anemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Anemia</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/NCT01716403
org study id: 1211
nct id: NCT01716403
lead sponsor: 
has dmc: No
The risk of severe anemia is increased in patients treated by tri-therapy compared to
      patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain
      unexplored but could also depend on the global exposure of telaprevir. The trough
      concentration or AUC of telaprevir could therefore be a predictive factor of the onset of
      anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of
      telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve
      tolerance and SVR.
observational model: Cohort
time perspective: Prospective
measure: telaprevir concentration and area under the curve
time frame: Day 0, Day 2, week 2, week 4, week 8 and week12
measure: ribavirin concentration and area under the curve
time frame: Day 0, Day 2, week 2, week 4, week 8 and week12
measure: viral load
time frame: Day 0
arm group label: HCV tritherapy and anemia
description: HCV-genotype 1 infected patients
intervention type: Biological
intervention name: Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition
arm group label: HCV tritherapy and anemia
plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Pierre Zarski, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
responsible party type: Sponsor
mesh term: Hepatitis
mesh term: Anemia