<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/NCT02201407</url>
  </required_header>
  <id_info>
    <org_study_id>ML29062</org_study_id>
    <nct_id>NCT02201407</nct_id>
  </id_info>
  <brief_title>An Observational Study in Participants With Chronic Hepatitis B (CHB) Receiving Therapy With Peginterferon Alfa-2a 40 Kilodaltons (kD) (PEGASYS) - The PRO B Study</brief_title>
  <official_title>Open, Multicenter, Local, Non-Randomized, Non-Interventional Study in Patients With Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40kD) - PRO 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 open--label, multicenter, national observational study will investigate the&#xD;
      effectiveness of standard of care treatment with peginterferon alfa-2a in participants with&#xD;
      chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV)&#xD;
      treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified&#xD;
      for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care&#xD;
      treatment) and for up to 24 weeks thereafter (72 weeks in total).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2014</start_date>
  <completion_date type="Actual">April 10, 2017</completion_date>
  <primary_completion_date type="Actual">April 10, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control</measure>
    <time_frame>Week 72</time_frame>
    <description>Sustained immune control is defined as a combined response: post-treatment HBeAg seroconversion, and HBV deoxyribonucleic acid (DNA) levels less than (&lt;) 2000 international units per milliliter (IU/mL), and alanine aminotransferase (ALT) normalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control</measure>
    <time_frame>Week 72</time_frame>
    <description>Sustained immune control is defined as a combined response: HBV DNA levels &lt;2000 IU/mL and ALT normalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion</measure>
    <time_frame>Week 72</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response</measure>
    <time_frame>Week 48</time_frame>
    <description>Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels &lt;2000 IU/mL, and ALT normalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response</measure>
    <time_frame>Week 48</time_frame>
    <description>Combined response is defined as: HBV DNA levels &lt;2000 IU/mL and ALT normalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs</measure>
    <time_frame>Up to 72 weeks</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>CHB Participants Treated With Peginterferon alfa-2a</arm_group_label>
    <description>As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with local labeling and not directed by the protocol. Participants with CHB who are receiving peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics, and in line with the local labeling will be followed for the duration of treatment with peginterferon alfa-2a (48 weeks) and up to 24 weeks after peginterferon alfa-2a treatment (72 weeks in total).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon alfa-2a</intervention_name>
    <description>Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.</description>
    <arm_group_label>CHB Participants Treated With Peginterferon alfa-2a</arm_group_label>
    <other_name>PEGASYS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants receiving treatment for CHB with peginterferon alfa-2a according to&#xD;
        standard of care and in line with the current summary of product characteristics and local&#xD;
        labeling who have no contraindication to peginterferon alfa-2a therapy as per the local&#xD;
        label. Target population are naïve participants (who have never received any HBV treatment)&#xD;
        and previously treated participants with NAs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HBeAg positive or HBeAg negative serologically proven CHB with or without cirrhosis&#xD;
             (histologically verified at some point in the past)&#xD;
&#xD;
          -  Baseline HBV DNA greater than (&gt;) 2000 IU/mL&#xD;
&#xD;
          -  Elevated serum ALT &gt; upper limit of normal (ULN)&#xD;
&#xD;
          -  Participants treated with previous NAs therapy are eligible for this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who have contraindications for peginterferon alfa-2a in accordance with&#xD;
             the approved summary of product characteristics (for example, severe psychiatric&#xD;
             diseases, immunological diseases, severe hepatic dysfunction or decompensated&#xD;
             cirrhosis of the liver severe retinopathy or thyroid dysfunction, autoimmune&#xD;
             hepatitis, history of severe pre-existing cardiac disease, or hypersensitivity to the&#xD;
             active substance, to alpha interferons, or to any of the excipients)&#xD;
&#xD;
          -  Participants with ALT &gt; 10 times of ULN or evidence of hepatocellular carcinoma&#xD;
&#xD;
          -  Participants with serological evidence of co-infection with hepatitis A virus,&#xD;
             hepatitis C virus, human immunodeficiency virus, or hepatitis D virus&#xD;
&#xD;
          -  Participants with decompensated liver disease&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  A history of liver transplantation or planned for liver transplantation&#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>Clinic for Gastroenterology and Hepatology</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center of Serbia; Institute For Infectious Diseases</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Zemun</name>
      <address>
        <city>Belgrade</city>
        <zip>11080</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Infectious Diseases CC Kragujevac</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinic for Infectious Diseases CC Nis</name>
      <address>
        <city>NIS</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Center Vojvodine; Clinic for Infectious Diseases; Clinic for Hematology</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 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>
  <!-- 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/NCT02201407
org study id: ML29062
nct id: NCT02201407
lead sponsor: 
This open--label, multicenter, national observational study will investigate the
      effectiveness of standard of care treatment with peginterferon alfa-2a in participants with
      chronic hepatitis B (CHB). Participants who have never received any hepatitis B virus (HBV)
      treatment and participants previously treated with nucleos(t)ide analogs (NAs) are qualified
      for enrollment. The observation period is 48 weeks (peginterferon alfa--2a standard of care
      treatment) and for up to 24 weeks thereafter (72 weeks in total).
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Hepatitis B Envelope Antigen (HBeAg)- Positive CHB Achieving Sustained Immune Control
time frame: Week 72
description: Sustained immune control is defined as a combined response: post-treatment HBeAg seroconversion, and HBV deoxyribonucleic acid (DNA) levels less than (<) 2000 international units per milliliter (IU/mL), and alanine aminotransferase (ALT) normalization.
measure: Percentage of Participants With HBeAg-Negative CHB Achieving Sustained Immune Control
time frame: Week 72
description: Sustained immune control is defined as a combined response: HBV DNA levels <2000 IU/mL and ALT normalization.
measure: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance or Seroconversion
time frame: Week 72
measure: Percentage of Participants With HBeAg-Positive CHB Achieving Combined Response
time frame: Week 48
description: Combined response is defined as: post-treatment HBeAg seroconversion, HBV DNA levels <2000 IU/mL, and ALT normalization.
measure: Percentage of Participants With HBeAg-Negative CHB Achieving Combined Response
time frame: Week 48
description: Combined response is defined as: HBV DNA levels <2000 IU/mL and ALT normalization.
measure: Percentage of Participants With Serious Adverse Events (SAEs) and Non-SAEs
time frame: Up to 72 weeks
arm group label: CHB Participants Treated With Peginterferon alfa-2a
description: As this is an observational study, treatment schedule will be at the clinician's discretion in accordance with local labeling and not directed by the protocol. Participants with CHB who are receiving peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics, and in line with the local labeling will be followed for the duration of treatment with peginterferon alfa-2a (48 weeks) and up to 24 weeks after peginterferon alfa-2a treatment (72 weeks in total).
intervention type: Drug
intervention name: Peginterferon alfa-2a
description: Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.
arm group label: CHB Participants Treated With Peginterferon alfa-2a
other name: PEGASYS
study pop: 
sampling method: Non-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: 
facility: 
facility: 
facility: 
facility: 
country: Serbia
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