<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/NCT01734018</url>
  </required_header>
  <id_info>
    <org_study_id>ML25614</org_study_id>
    <nct_id>NCT01734018</nct_id>
  </id_info>
  <brief_title>An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B</brief_title>
  <official_title>A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This multicenter, prospective, observational study will evaluate the efficacy and safety of&#xD;
      Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive&#xD;
      or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys&#xD;
      according to standard of care and the summary od product characteristics/local labelling will&#xD;
      be followed for the duration of treatment and up to 2 years of follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up</measure>
    <time_frame>from baseline to up to approximately 3 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up</measure>
    <time_frame>from baseline to up to approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with sustained immune control (sustained HBV DNA &lt;2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with normalisation of serum alanine transaminase (ALT) levels</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with HBsAg clearance/seroconversion</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 4 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with chronic hepatitis B receiving treatment with Pegasys&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or&#xD;
             without cirrhosis&#xD;
&#xD;
          -  Elevated serum ALT &gt; ULN (upper limit of normal) but &lt;/=10 x ULN according to local&#xD;
             label&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contra-indications to Pegasys as detailed in the label&#xD;
&#xD;
          -  Co-infection with hepatitis A, hepatitis B or HIV&#xD;
&#xD;
          -  Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is&#xD;
             contra-indicated according to telbivudine label)&#xD;
&#xD;
          -  Pregnant or breastfeeding 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>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01734018
org study id: ML25614
nct id: NCT01734018
lead sponsor: 
This multicenter, prospective, observational study will evaluate the efficacy and safety of
      Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive
      or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys
      according to standard of care and the summary od product characteristics/local labelling will
      be followed for the duration of treatment and up to 2 years of follow-up.
observational model: Cohort
time perspective: Prospective
measure: Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up
time frame: from baseline to up to approximately 3 years
measure: Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up
time frame: from baseline to up to approximately 3 years
measure: Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients)
time frame: approximately 4 years
measure: Percentage of patients with normalisation of serum alanine transaminase (ALT) levels
time frame: approximately 4 years
measure: Percentage of patients with HBsAg clearance/seroconversion
time frame: approximately 4 years
measure: Safety: Incidence of adverse events
time frame: approximately 4 years
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis