<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/NCT01667432</url>
  </required_header>
  <id_info>
    <org_study_id>ML25626</org_study_id>
    <nct_id>NCT01667432</nct_id>
  </id_info>
  <brief_title>An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B</brief_title>
  <official_title>A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)</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 prospective, multicenter, observational study will evaluate on-treatment predictors of&#xD;
      response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving&#xD;
      treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the&#xD;
      summary of product characteristics. Data will be collected from patients for the duration of&#xD;
      their treatment and for up to 24 weeks thereafter.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 8, 2011</start_date>
  <completion_date type="Actual">August 12, 2014</completion_date>
  <primary_completion_date type="Actual">August 12, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Suppression of HBV DNA to &lt; 2,000 IU/ml at the End of the Study</measure>
    <time_frame>At the end of the study (Week 36)</time_frame>
    <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients With Suppression of HBV DNA &lt; 2,000 IU/ml</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Suppression of HBV DNA to &lt; 80 IU/ml at the End of Treatment</measure>
    <time_frame>At the end of treatment (Week 24)</time_frame>
    <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of Adverse Events</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">141</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Peginterferon alfa-2a</arm_group_label>
    <description>Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Peginterferon alfa-2a</intervention_name>
    <description>Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.</description>
    <arm_group_label>Peginterferon alfa-2a</arm_group_label>
    <other_name>PEGASYS®</other_name>
    <other_name>RO0258310</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic hepatitis B on treatment with PEGASYS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥ 18 years of age.&#xD;
&#xD;
          -  Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or&#xD;
             without cirrhosis.&#xD;
&#xD;
          -  Elevated alanine aminotransferase (ALT) &gt; upper limit of normal (ULN) but ≤ 10 x ULN&#xD;
             according to local label.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.&#xD;
&#xD;
          -  Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).&#xD;
&#xD;
          -  Concomitant treatment with telbivudine.&#xD;
&#xD;
          -  Pregnant or lactating women.&#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>Mhat - Pleven; Clinic of Gastroenterology</name>
      <address>
        <city>Pleven</city>
        <zip>5800</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umhat St. Georgi; Clinical of Gastroenterology</name>
      <address>
        <city>Plovdiv</city>
        <zip>4002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT Tokuda Hospital Sofia; Department of Gastroenterology at Clinic of Internal Deseases</name>
      <address>
        <city>Sofia</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMHAT Alexandrovska EAD; Gastroenterology</name>
      <address>
        <city>Sofia</city>
        <zip>1431</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mhat Queenjoanna; Clinic of Gastroenterology</name>
      <address>
        <city>Sofia</city>
        <zip>1527</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy; Gastroenterology</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mhat St. Ivan Rilski; Clinic of Gastroenterology</name>
      <address>
        <city>Sofia</city>
        <zip>1612</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mhat St. Zagora; Clinical of Gastroenterology</name>
      <address>
        <city>Stara Zagora</city>
        <zip>6000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mhat Sveta Marina; Clinic of Gastroenterology</name>
      <address>
        <city>Varna</city>
        <zip>9010</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bulgaria</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <results_first_submitted>October 1, 2015</results_first_submitted>
  <results_first_submitted_qc>November 3, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 7, 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peginterferon alfa-2a</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Peginterferon Alfa-2a</title>
          <description>Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Premature Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Failure to Return</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved to Another Center</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Refused Treatment/Withdrew Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Insufficient Therapeutic Response</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Principal Investigator Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing Information</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.</population>
      <group_list>
        <group group_id="B1">
          <title>Peginterferon Alfa-2a</title>
          <description>Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="139"/>
          </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="40.10" spread="10.45"/>
                  </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="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Suppression of HBV DNA to &lt; 2,000 IU/ml at the End of the Study</title>
        <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).</description>
        <time_frame>At the end of the study (Week 36)</time_frame>
        <population>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.</population>
        <group_list>
          <group group_id="O1">
            <title>Peginterferon Alfa-2a</title>
            <description>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Suppression of HBV DNA to &lt; 2,000 IU/ml at the End of the Study</title>
          <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).</description>
          <population>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="139"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8" lower_limit="30.70" upper_limit="47.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Suppression of HBV DNA &lt; 2,000 IU/ml</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Suppression of HBV DNA to &lt; 80 IU/ml at the End of Treatment</title>
        <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.</description>
        <time_frame>At the end of treatment (Week 24)</time_frame>
        <population>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Peginterferon Alfa-2a</title>
            <description>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Suppression of HBV DNA to &lt; 80 IU/ml at the End of Treatment</title>
          <description>Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.</description>
          <population>Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a. Only participants with available HBsAg measurements were included in the analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HBeAg positive (n = 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4" lower_limit="10.92" upper_limit="69.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HBeAg negative (n = 33)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" lower_limit="19.8" upper_limit="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety: Incidence of Adverse Events</title>
        <time_frame>approximately 3 years</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Safety population: All participants who received at least 1 dose of peginterferon alfa-2a and had at least 1 post-baseline safety assessment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Peginterferon Alfa-2a</title>
          <description>Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (18.0)</default_vocab>
        <default_assessment>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="78" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Leucopenia</sub_title>
                <counts group_id="E1" events="23" subjects_affected="23" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="42" subjects_affected="42" subjects_at_risk="139"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="139"/>
              </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>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/NCT01667432
org study id: ML25626
nct id: NCT01667432
lead sponsor: 
This prospective, multicenter, observational study will evaluate on-treatment predictors of
      response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving
      treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the
      summary of product characteristics. Data will be collected from patients for the duration of
      their treatment and for up to 24 weeks thereafter.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
time frame: At the end of the study (Week 36)
description: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml).
measure: Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
time frame: approximately 3 years
measure: In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
time frame: approximately 3 years
measure: Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment
time frame: At the end of treatment (Week 24)
description: Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative.
measure: HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative
time frame: approximately 3 years
measure: Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients
time frame: approximately 3 years
measure: Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients
time frame: approximately 3 years
measure: Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio
time frame: approximately 3 years
measure: Safety: Incidence of Adverse Events
time frame: approximately 3 years
arm group label: Peginterferon alfa-2a
description: Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
intervention type: Biological
intervention name: Peginterferon alfa-2a
description: Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
arm group label: Peginterferon alfa-2a
other name: PEGASYS®
other name: RO0258310
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: 
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country: Bulgaria
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Peginterferon alfa-2a
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 