<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/NCT01671046</url>
  </required_header>
  <id_info>
    <org_study_id>ML27944</org_study_id>
    <nct_id>NCT01671046</nct_id>
  </id_info>
  <brief_title>An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection</brief_title>
  <official_title>Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multi-center, prospective observational study will evaluate the correlation of liver&#xD;
      biopsy and transient elastography in liver fibrosis assessment in patients with chronic&#xD;
      hepatitis C. Data will be collected for 96 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of liver elasticity evolution with viral kinetics</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of liver fibrosis stages with sustained virological response (SVR)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of patients characteristics with sustained virological response</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic transient elastography (M-transducer)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hepatic transient elastography (XL-transducer)</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of hepatic steatosis score with sustained virological response</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">123</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biopsy of the liver&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic hepatitis C&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Chronic Hepatitis C infection (mono-infection or co-infection with human&#xD;
             immunodeficiency virus [HIV])&#xD;
&#xD;
          -  Detectable level of hepatitis C RNA&#xD;
&#xD;
          -  Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon&#xD;
             plus ribavirin, and boceprevir or telaprevir according to local guidelines&#xD;
&#xD;
          -  Last liver biopsy performed no later than 3 months prior to enrolment to study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-infection with hepatitis B virus&#xD;
&#xD;
          -  Previous treatment with pegylated interferon and ribavirin&#xD;
&#xD;
          -  Participation in another clinical study in the last 12 months prior to study start&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>20270-004</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>21941-590</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Botucatu</city>
        <state>SP</state>
        <zip>18600-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13026-210</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13060-803</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Santo Andre</city>
        <state>SP</state>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04040-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>04040-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sorocaba</city>
        <state>SP</state>
        <zip>18047-600</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</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 A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Liver Cirrhosis</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/NCT01671046
org study id: ML27944
nct id: NCT01671046
lead sponsor: 
This multi-center, prospective observational study will evaluate the correlation of liver
      biopsy and transient elastography in liver fibrosis assessment in patients with chronic
      hepatitis C. Data will be collected for 96 weeks.
observational model: Cohort
time perspective: Prospective
measure: Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start
time frame: 24 months
measure: Correlation of liver elasticity evolution with viral kinetics
time frame: 24 months
measure: Safety: incidence of adverse events
time frame: 24 months
measure: Correlation of liver fibrosis stages with sustained virological response (SVR)
time frame: 24 months
measure: Correlation of patients characteristics with sustained virological response
time frame: 24 months
measure: Hepatic transient elastography (M-transducer)
time frame: 24 months
measure: Hepatic transient elastography (XL-transducer)
time frame: 24 months
measure: Correlation of hepatic steatosis score with sustained virological response
time frame: 24 months
measure: Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy
time frame: 24 months
measure: Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients
time frame: 24 months
arm group label: Cohort
Biopsy of the liver
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Liver Cirrhosis