<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/NCT01697501</url>
  </required_header>
  <id_info>
    <org_study_id>ML28470</org_study_id>
    <secondary_id>2012-002777-56</secondary_id>
    <nct_id>NCT01697501</nct_id>
  </id_info>
  <brief_title>A Study Evaluating IL28B Polymorphism in Patients With HBeAg-Negative Chronic Hepatitis B Treated With Pegasys (Peginterferon Alfa-2a) in Study ML18253</brief_title>
  <official_title>Cross-sectional Multicenter Study Evaluating the IL28B Polymorphism in Patients With HBeAg-negative Chronic Hepatitis B Treated With Pegylated Interferon Alfa-2a in the Course of Peg.Be.Liver Study</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 cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with&#xD;
      HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the&#xD;
      predecessor ML18253 study. The study consists of a single visit where eligible patients will&#xD;
      undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2012</start_date>
  <completion_date type="Actual">June 21, 2013</completion_date>
  <primary_completion_date type="Actual">June 21, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)</measure>
    <time_frame>EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF</measure>
    <time_frame>EoF</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)</measure>
    <time_frame>EoT, as defined in the predecessor study, was at Week 48 or Week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT</measure>
    <time_frame>EoT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</measure>
    <time_frame>EoT and EoF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</measure>
    <time_frame>EoT and EoF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</measure>
    <time_frame>EoT and EoF</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</measure>
    <time_frame>EoT and EoF</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Chronic hepatitis B patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interleukin 28B testing</intervention_name>
    <description>Blood sampling for IL28B genotyping</description>
    <arm_group_label>Chronic hepatitis B patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Chronic hepatitis B&#xD;
&#xD;
          -  Previous participation in study ML18253&#xD;
&#xD;
          -  Administration of at least one dose of the study drug during ML18253 study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients not satisfying the above inclusion criteria will not be enrolled in the study&#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>Az. Osp. S. Sebastiano; Divisione Malattie Infettive</name>
      <address>
        <city>Caserta</city>
        <state>Campania</state>
        <zip>81100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Cardarelli; Unita Operativa A Struttura Complessa Di Epatologia</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In</name>
      <address>
        <city>Bologna</city>
        <state>Emilia-Romagna</state>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Uni Ria Di Parma; Gastro-Enterology</name>
      <address>
        <city>Parma</city>
        <state>Emilia-Romagna</state>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ospedale Maggiore Policlinico; Gastroenterologia</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Maggiore Policlinico; Iii Divisione Medicina Generale</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Policlinico Consorziale di Bari; Clinica Malattie Infettive</name>
      <address>
        <city>Bari</city>
        <state>Puglia</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale de Bellis; Reparto Medicina Generale</name>
      <address>
        <city>Castellana Grotte</city>
        <state>Puglia</state>
        <zip>70013</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uni Di Cagliari; Dept. Di Scienze Mediche</name>
      <address>
        <city>Cagliari</city>
        <state>Sardegna</state>
        <zip>09042</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Di Clinica Medica 1 A; Divisione Di Medicina Generale E Gastroenterologia</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia</name>
      <address>
        <city>Pisa</city>
        <state>Toscana</state>
        <zip>56124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az. Osp. Di Padova; Dipart. Scienze Chirurgiche E Gastroent.</name>
      <address>
        <city>Padova</city>
        <state>Veneto</state>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <results_first_submitted>June 10, 2015</results_first_submitted>
  <results_first_submitted_qc>July 7, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 10, 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 B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants in the safety analysis set included 88 patients with HBeAg-negative chronic hepatitis B enrolled at 12 study centers in Italy.</recruitment_details>
      <pre_assignment_details>Participants in the full analysis set included 86 previously enrolled in the predecessor study ML18253 (NCT01095835), during which they were treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Chronic Hepatitis B Patients</title>
          <description>Interleukin 28B testing: Blood sampling for IL28B genotyping</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chronic Hepatitis B Patients</title>
          <description>Interleukin 28B testing: Blood sampling for IL28B genotyping</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="86"/>
          </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="45.7" spread="9.6"/>
                  </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="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)</title>
        <time_frame>EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.</time_frame>
        <population>Full analysis set (FAS), defined as all subjects who completed</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;CC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O2">
            <title>&quot;TC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O3">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O4">
            <title>&quot;TC+TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)</title>
          <population>Full analysis set (FAS), defined as all subjects who completed</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="35"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="17.1"/>
                    <measurement group_id="O3" value="20.0"/>
                    <measurement group_id="O4" value="17.6"/>
                    <measurement group_id="O5" value="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.7831</p_value>
            <method>univariate logistic analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.29</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF</title>
        <time_frame>EoF</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O2">
            <title>&quot;GT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O3">
            <title>&quot;GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O4">
            <title>&quot;GT+GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF</title>
          <population>FAS</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="52"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1"/>
                    <measurement group_id="O2" value="12.9"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="11.8"/>
                    <measurement group_id="O5" value="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.1951</p_value>
            <method>univariate logistic analysis</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.66</ci_lower_limit>
            <ci_upper_limit>7.67</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)</title>
        <time_frame>EoT, as defined in the predecessor study, was at Week 48 or Week 96</time_frame>
        <population>Full analysis set (FAS), defined as all subjects who completed</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;CC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O2">
            <title>&quot;TC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O3">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O4">
            <title>&quot;TC+TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)</title>
          <population>Full analysis set (FAS), defined as all subjects who completed</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="35"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.3"/>
                    <measurement group_id="O2" value="65.9"/>
                    <measurement group_id="O3" value="50.0"/>
                    <measurement group_id="O4" value="62.7"/>
                    <measurement group_id="O5" value="67.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.2642</p_value>
            <method>Wald Chi Square</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT</title>
        <time_frame>EoT</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O2">
            <title>&quot;GT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O3">
            <title>&quot;GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O4">
            <title>&quot;GT+GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT</title>
          <population>FAS</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="52"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                    <measurement group_id="O2" value="54.8"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="55.9"/>
                    <measurement group_id="O5" value="67.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.0672</p_value>
            <method>Wald Chi Square</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</title>
        <time_frame>EoT and EoF</time_frame>
        <population>Full analysis set (FAS), defined as all subjects who completed</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;CC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O2">
            <title>&quot;TC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O3">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O4">
            <title>&quot;TC+TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</title>
          <population>Full analysis set (FAS), defined as all subjects who completed</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="35"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EoT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="2.4"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="2.0"/>
                    <measurement group_id="O5" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EoF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="4.9"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="3.9"/>
                    <measurement group_id="O5" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</title>
        <time_frame>EoT and EoF</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O2">
            <title>&quot;GT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O3">
            <title>&quot;GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O4">
            <title>&quot;GT+GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg &lt; 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</title>
          <population>FAS</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="52"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EoT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EoF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</title>
        <time_frame>EoT and EoF</time_frame>
        <population>Full analysis set (FAS), defined as all subjects who completed</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;CC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O2">
            <title>&quot;TC&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O3">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O4">
            <title>&quot;TC+TT&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs12979860</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF</title>
          <population>Full analysis set (FAS), defined as all subjects who completed</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="35"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="51"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EoT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="7.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="5.9"/>
                    <measurement group_id="O5" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EoF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="4.9"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="3.9"/>
                    <measurement group_id="O5" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</title>
        <time_frame>EoT and EoF</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>&quot;TT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O2">
            <title>&quot;GT&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O3">
            <title>&quot;GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O4">
            <title>&quot;GT+GG&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
          <group group_id="O5">
            <title>&quot;Overall&quot;</title>
            <description>at IL28B genotype rs8099917</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF</title>
          <population>FAS</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="52"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="34"/>
                <count group_id="O5" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EoT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EoF</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                    <measurement group_id="O5" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The study consisted of a single visit where eligible patients undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit. All subjects enrolled are included in the safety analysis set.</time_frame>
      <desc>Adverse events were to be reported on a per subject basis by severity and relationship to study procedures.</desc>
      <group_list>
        <group group_id="E1">
          <title>Chronic Hepatitis B Patients</title>
          <description>Interleukin 28B testing: Blood sampling for IL28B genotyping</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="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </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>Hoffmann-La Roche</organization>
      <phone>1-800-821-8590</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/NCT01697501
org study id: ML28470
secondary id: 2012-002777-56
nct id: NCT01697501
lead sponsor: 
This cross-sectional multicenter study will evaluate the IL28B polymorphism in patients with
      HBeAg-negative chronic hepatitis B treated with Pegasys (peginterferon alfa-2a) in the
      predecessor ML18253 study. The study consists of a single visit where eligible patients will
      undergo a blood test for IL28B genotyping, with a phone follow-up 7 days after the visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Percentage of Participants With Sustained Viral Response (SVR) Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Follow-up (EoF)
time frame: EoF, as defined in the predecessor study, was at 48 weeks after the end of treatment.
measure: Percentage of Participants With SVR Defined as HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoF
time frame: EoF
measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs12979860 at End of Treatment (EoT)
time frame: EoT, as defined in the predecessor study, was at Week 48 or Week 96
measure: Percentage of Participants With HBV DNA ≤ 2000 IU/ml at IL28B Genotype rs8099917 at EoT
time frame: EoT
measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
time frame: EoT and EoF
measure: Percentage of Participants With HBsAg < 0.05 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
time frame: EoT and EoF
measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs12979860 at EoT and EoF
time frame: EoT and EoF
measure: Percentage of Participants With HBsAg ≤ 10 IU/ml at IL28B Genotype rs8099917 at EoT and EoF
time frame: EoT and EoF
arm group label: Chronic hepatitis B patients
arm group type: Experimental
intervention type: Other
intervention name: Interleukin 28B testing
description: Blood sampling for IL28B genotyping
arm group label: Chronic hepatitis B patients
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: 
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 