<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/NCT01679834</url>
  </required_header>
  <id_info>
    <org_study_id>ML25724</org_study_id>
    <nct_id>NCT01679834</nct_id>
  </id_info>
  <brief_title>An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C</brief_title>
  <official_title>A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers</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 multicenter, observational study will assess the efficacy and the safety of Pegasys&#xD;
      (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.&#xD;
      Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local&#xD;
      guidelines. Data will be collected for 96 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 24, 2014</start_date>
  <completion_date type="Actual">July 14, 2017</completion_date>
  <primary_completion_date type="Actual">July 14, 2017</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>Sustained virological response</measure>
    <time_frame>24 weeks after end of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rapid virological response</measure>
    <time_frame>4 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Virological Response</measure>
    <time_frame>12 weeks after start of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: incidence of adverse events</measure>
    <time_frame>up to 24 weeks after end of treatment</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">7500</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic hepatitis C infection&#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;
          -  Diagnosis of chronic hepatitis C&#xD;
&#xD;
          -  Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease&#xD;
             inhibitor according to local label&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications against Pegasys or Copegus&#xD;
&#xD;
          -  Not willing or unable to sign written informed consent form&#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>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Herne</city>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2018</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>
  </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/NCT01679834
org study id: ML25724
nct id: NCT01679834
lead sponsor: 
This multicenter, observational study will assess the efficacy and the safety of Pegasys
      (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C.
      Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local
      guidelines. Data will be collected for 96 weeks.
observational model: Cohort
time perspective: Prospective
measure: Sustained virological response
time frame: 24 weeks after end of treatment
measure: Rapid virological response
time frame: 4 weeks after start of treatment
measure: Early Virological Response
time frame: 12 weeks after start of treatment
measure: Safety: incidence of adverse events
time frame: up to 24 weeks after end of treatment
arm group label: Cohort
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: 
country: Germany
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis