<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/NCT01705717</url>
  </required_header>
  <id_info>
    <org_study_id>ML25436</org_study_id>
    <nct_id>NCT01705717</nct_id>
  </id_info>
  <brief_title>A Retrospective Study of Real World Treatment Outcomes of Patients With Chronic Hepatitis C</brief_title>
  <official_title>Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis</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 retrospective, observational study will assess the real world treatment out comes in the&#xD;
      management of patients with chronic hepatitis C. No prospective ass essment or procedure with&#xD;
      patients during this study will be conducted. Data wil l be collected from patient medical&#xD;
      records of the year 2000-2011.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2011</start_date>
  <completion_date type="Actual">May 1, 2012</completion_date>
  <primary_completion_date type="Actual">May 1, 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy</measure>
    <time_frame>6 months</time_frame>
    <description>SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Were HCV Seronegative at the End of Treatment</measure>
    <time_frame>End of Study, up to 36 months after diagnosis.</time_frame>
    <description>End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion</measure>
    <time_frame>End of Study, up to 36 months after diagnosis.</time_frame>
    <description>HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Progressed From CHC to Cirrhosis</measure>
    <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)</measure>
    <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died</measure>
    <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis</time_frame>
    <description>Any cause of death (including non-liver disease related) was reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">49</enrollment>
  <condition>Hepatitis C, Chronic</condition>
  <arm_group>
    <arm_group_label>cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective survey of medical records of patients with chronic hepatitis C&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010&#xD;
&#xD;
          -  Availability of data for at least 6 months following the diagnosis date&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who participated in an investigational clinical trial&#xD;
&#xD;
          -  Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency&#xD;
             virus (HIV)&#xD;
&#xD;
          -  Patients with known severe medical conditions that are contraindicated to HCV&#xD;
             treatment&#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>
      <name>Faculty of Medicine Vajira Hospital; Division of Gastroenterology and Hepatology</name>
      <address>
        <city>Bangkok</city>
        <zip>10300</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <results_first_submitted>January 5, 2015</results_first_submitted>
  <results_first_submitted_qc>January 5, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 12, 2015</results_first_posted>
  <last_update_submitted>March 10, 2017</last_update_submitted>
  <last_update_submitted_qc>March 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</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>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only</title>
          <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
        </group>
        <group group_id="P2">
          <title>Hepatitis C Virus (HCV) - Related Cirrhosis Observation Only</title>
          <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Non-Cirrhotic CHC Observation Only</title>
          <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
        </group>
        <group group_id="B2">
          <title>HCV - Related Cirrhosis Observation Only</title>
          <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="37"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="49"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.8" spread="10.9"/>
                    <measurement group_id="B2" value="53.9" spread="8.2"/>
                    <measurement group_id="B3" value="47.2" spread="10.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy</title>
        <description>SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.</description>
        <time_frame>6 months</time_frame>
        <population>All enrolled participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy</title>
          <description>SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.</description>
          <population>All enrolled participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.5"/>
                    <measurement group_id="O2" value="58.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Were HCV Seronegative at the End of Treatment</title>
        <description>End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.</description>
        <time_frame>End of Study, up to 36 months after diagnosis.</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Were HCV Seronegative at the End of Treatment</title>
          <description>End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.</description>
          <population>All enrolled participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.9"/>
                    <measurement group_id="O2" value="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion</title>
        <description>HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.</description>
        <time_frame>End of Study, up to 36 months after diagnosis.</time_frame>
        <population>All enrolled participants;</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion</title>
          <description>HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.</description>
          <population>All enrolled participants;</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Virological Relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biochemical Relapse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Progressed From CHC to Cirrhosis</title>
        <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis.</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Progressed From CHC to Cirrhosis</title>
          <population>All enrolled participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.034</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)</title>
        <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis.</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)</title>
          <population>All enrolled participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.007</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died</title>
        <description>Any cause of death (including non-liver disease related) was reported.</description>
        <time_frame>Diagnosis and End of Study, up to 36 months after diagnosis</time_frame>
        <population>All enrolled participants</population>
        <group_list>
          <group group_id="O1">
            <title>Non-Cirrhotic CHC Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
          <group group_id="O2">
            <title>HCV - Related Cirrhosis Observation Only</title>
            <description>Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died</title>
          <description>Any cause of death (including non-liver disease related) was reported.</description>
          <population>All enrolled participants</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were recorded from the begininng of treatment through the end of the study, approximately 36 months. This was a retrospective analysis study; safety reporting was generated spontaneously by physician discretion.</time_frame>
      <desc>All participants for whom safety data was collected are included in the safety analysis. Systematic collection of safety data was not mandatory according to the protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Leucopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Severe anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Intracranial hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Communications</name_or_title>
      <organization>Hoffman-LaRoche</organization>
      <phone>800-821-8590</phone>
      <email>genentech@druginfo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01705717
org study id: ML25436
nct id: NCT01705717
lead sponsor: 
This retrospective, observational study will assess the real world treatment out comes in the
      management of patients with chronic hepatitis C. No prospective ass essment or procedure with
      patients during this study will be conducted. Data wil l be collected from patient medical
      records of the year 2000-2011.
observational model: Cohort
time perspective: Retrospective
measure: Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
time frame: 6 months
description: SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.
measure: Percentage of Participants Who Were HCV Seronegative at the End of Treatment
time frame: End of Study, up to 36 months after diagnosis.
description: End-of-treatment response (ETR) was defined as a negative result upon PCR RNA diagnostic testing at the end of treatment.
measure: Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion
time frame: End of Study, up to 36 months after diagnosis.
description: HCV relapse was determined by PCR RNA diagnostic testing. Virological relapse was defined as subsequent reappearance of serum HCV RNA after completion of therapy in participants who achieved end of treatment virological response (undetectable HCV RNA). Biochemical relapse was defined as subsequent rise in serum alanine aminotransferase (ALT) level after end of treatment with normal ALT.
measure: Percentage of Participants Who Progressed From CHC to Cirrhosis
time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)
time frame: Diagnosis and End of Study, up to 36 months after diagnosis.
measure: Percentage of Participants Who Died
time frame: Diagnosis and End of Study, up to 36 months after diagnosis
description: Any cause of death (including non-liver disease related) was reported.
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: 
country: Thailand
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 