xml: <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/NCT05970289</url>
    </required_header>
    <id_info>
      <org_study_id>BRII-835-002</org_study_id>
      <nct_id>NCT05970289</nct_id>
    </id_info>
    <brief_title>Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients</brief_title>
    <official_title>A Phase 2 Multicenter, Randomized, Open-label Study to Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and Pegylated Interferon Alpha (PEG-IFNα) Combination Therapy for the Treatment of Chronic Hepatitis B Virus (HBV) Infection</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brii Biosciences Limited</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Vir Biotechnology, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Brii Biosciences Limited</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with&#xD;
        different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus&#xD;
        (HBV) infection.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of participants with HBsAg loss at end of treatment</measure>
      <time_frame>Up to Week 48</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants with HBsAg loss at 24 weeks post-end of treatment</measure>
      <time_frame>Up to Week 72</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants with treatment-emergent adverse events (TEAEs)</measure>
      <time_frame>Up to Week 72</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Proportion of participants with serious adverse events (SAEs)</measure>
      <time_frame>Up to Week 72</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Chronic Hepatitis B Virus Infection</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive multiple doses of PEG-IFNα for 48 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>PEG-IFNα</intervention_name>
      <description>PEG-IFNα will be given via subcutaneous injection</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
      <other_name>pegylated interferon alfa</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BRII-835</intervention_name>
      <description>BRII-835 will be given via subcutaneous injection</description>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male or female aged 18-60.&#xD;
  &#xD;
            -  Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.&#xD;
  &#xD;
            -  Chronic HBV infection for ≥ 6 months.&#xD;
  &#xD;
            -  On NRTI therapy for at least 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any clinically significant chronic or acute medical condition that makes the&#xD;
               participant unsuitable for participation.&#xD;
  &#xD;
            -  Significant liver fibrosis or cirrhosis.&#xD;
  &#xD;
            -  History or evidence of drug or alcohol abuse.&#xD;
  &#xD;
            -  History of intolerance to SC injection.&#xD;
  &#xD;
            -  History of chronic liver disease from any cause other than chronic HBV infection.&#xD;
  &#xD;
            -  History of hepatic decompensation.&#xD;
  &#xD;
            -  Contraindications to the use of Peg-IFNα.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xiaofei Chen</last_name>
      <role>Study Director</role>
      <affiliation>Brii Biosciences Limited</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carol Xu</last_name>
      <phone>+86 10 62998808</phone>
      <email>Carol.Xu@briibio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Investigative Site 61001</name>
        <address>
          <city>Kingswood</city>
          <state>New South Wales</state>
          <zip>2747</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 61002</name>
        <address>
          <city>Birtinya</city>
          <state>Queensland</state>
          <zip>4575</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 61003</name>
        <address>
          <city>Melbourne</city>
          <state>Victoria</state>
          <zip>3004</zip>
          <country>Australia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 86001</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 85201</name>
        <address>
          <city>Hong Kong</city>
          <state>Hong Kong</state>
          <zip>999077</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 85202</name>
        <address>
          <city>Hong Kong</city>
          <state>Hong Kong</state>
          <zip>999077</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 85203</name>
        <address>
          <city>Kowloon</city>
          <state>Hong Kong</state>
          <zip>999077</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 85204</name>
        <address>
          <city>NEW Territories</city>
          <state>Hong Kong</state>
          <zip>999077</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 88601</name>
        <address>
          <city>Kaohsiung</city>
          <state>Taiwan</state>
          <zip>80756</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 88602</name>
        <address>
          <city>Taipei</city>
          <state>Taiwan</state>
          <zip>10041</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 88603</name>
        <address>
          <city>Taipei</city>
          <state>Taiwan</state>
          <zip>11217</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 88604</name>
        <address>
          <city>Taoyuan</city>
          <state>Taiwan</state>
          <zip>333</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 82001</name>
        <address>
          <city>Busan</city>
          <zip>49241</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 82002</name>
        <address>
          <city>Chuncheon-si</city>
          <zip>24253</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 82004</name>
        <address>
          <city>Daegu</city>
          <zip>41566</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 82003</name>
        <address>
          <city>Seoul</city>
          <zip>6351</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 60005</name>
        <address>
          <city>Johor Bahru</city>
          <state>Johor</state>
          <zip>80100</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 60001</name>
        <address>
          <city>Sabah</city>
          <state>KOTA Kinabalu</state>
          <zip>88586</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 60003</name>
        <address>
          <city>Kuala Lumpur</city>
          <state>Kuala LUMP</state>
          <zip>59000</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 60004</name>
        <address>
          <city>Kuala Lumpur</city>
          <state>WP</state>
          <zip>59100</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 60002</name>
        <address>
          <city>Melaka</city>
          <zip>59000</zip>
          <country>Malaysia</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 65001</name>
        <address>
          <city>Singapore</city>
          <zip>169856</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 65002</name>
        <address>
          <city>Singapore</city>
          <zip>529889</zip>
          <country>Singapore</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66003</name>
        <address>
          <city>Bangkok</city>
          <zip>10330</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66002</name>
        <address>
          <city>Bangkok</city>
          <zip>10400</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66004</name>
        <address>
          <city>Bangkok</city>
          <zip>10400</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66005</name>
        <address>
          <city>Khon Kaen</city>
          <zip>40002</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66001</name>
        <address>
          <city>Nonthaburi</city>
          <zip>11000</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Investigative Site 66006</name>
        <address>
          <city>Nonthaburi</city>
          <zip>11000</zip>
          <country>Thailand</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Australia</country>
      <country>China</country>
      <country>Korea, Republic of</country>
      <country>Malaysia</country>
      <country>Singapore</country>
      <country>Thailand</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</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>Infections</mesh_term>
      <mesh_term>Hepatitis B</mesh_term>
      <mesh_term>Hepatitis B, Chronic</mesh_term>
      <mesh_term>Herpesviridae Infections</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
      <mesh_term>Hepatitis, Chronic</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Interferons</mesh_term>
      <mesh_term>Interferon-alpha</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970289
  org study id: BRII-835-002
  nct id: NCT05970289
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with
        different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus
        (HBV) infection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Proportion of participants with HBsAg loss at end of treatment
  time frame: Up to Week 48
  measure: Proportion of participants with HBsAg loss at 24 weeks post-end of treatment
  time frame: Up to Week 72
  measure: Proportion of participants with treatment-emergent adverse events (TEAEs)
  time frame: Up to Week 72
  measure: Proportion of participants with serious adverse events (SAEs)
  time frame: Up to Week 72
  arm group label: Cohort 1
  arm group type: Experimental
  description: Participants will receive multiple doses of PEG-IFNα for 48 weeks.
  arm group label: Cohort 2
  arm group type: Experimental
  description: Participants will receive multiple doses of higher dose level of BRII-835 + PEG-IFNα for 48 weeks.
  arm group label: Cohort 3
  arm group type: Experimental
  description: Participants will receive multiple doses of lower dose level of BRII-835 + PEG-IFNα for 48 weeks.
  intervention type: Biological
  intervention name: PEG-IFNα
  description: PEG-IFNα will be given via subcutaneous injection
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  other name: pegylated interferon alfa
  intervention type: Drug
  intervention name: BRII-835
  description: BRII-835 will be given via subcutaneous injection
  arm group label: Cohort 2
  arm group label: Cohort 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Xiaofei Chen
  role: Study Director
  affiliation: Brii Biosciences Limited
  last name: Carol Xu
  phone: +86 10 62998808
  email: Carol.Xu@briibio.com
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Australia
  country: China
  country: Korea, Republic of
  country: Malaysia
  country: Singapore
  country: Thailand
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Hepatitis B
  mesh term: Hepatitis B, Chronic
  mesh term: Herpesviridae Infections
  mesh term: Hepatitis
  mesh term: Hepatitis, Chronic
  mesh term: Interferons
  mesh term: Interferon-alpha
  sharing ipd: No