<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/NCT04412863</url>
  </required_header>
  <id_info>
    <org_study_id>VIR-2218-1001-PEG-IFNα</org_study_id>
    <nct_id>NCT04412863</nct_id>
  </id_info>
  <brief_title>Study of VIR-2218 With or Without Pegylated Interferon Alpha-2a for Treatment of Chronic Hepatitis B Virus Infection</brief_title>
  <official_title>A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218 Alone or in Combination With Pegylated Interferon Alpha-2a</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vir Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alnylam Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vir Biotechnology, Inc.</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 is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will&#xD;
      receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be&#xD;
      assessed for safety, tolerability, pharmacokinetics, and antiviral activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 3, 2020</start_date>
  <completion_date type="Anticipated">April 2024</completion_date>
  <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with Adverse Events as assessed by CTCAE v5.0</measure>
    <time_frame>Up to 148 Weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings</measure>
    <time_frame>Up to 148 Weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean maximum reduction of serum HBsAg at any timepoint</measure>
    <time_frame>Up to 144 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint</measure>
    <time_frame>Up to 144 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months</measure>
    <time_frame>Up to 144 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with anti-HBs seroconversion at any timepoint</measure>
    <time_frame>Up to 144 Weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint</measure>
    <time_frame>Up to 96 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Cohort 1d</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2d</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3d</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1e</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2e</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3e</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1f</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2f</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3f</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>VIR-2218</intervention_name>
    <description>VIR-2218 given by subcutaneous injection</description>
    <arm_group_label>Cohort 1d</arm_group_label>
    <arm_group_label>Cohort 1e</arm_group_label>
    <arm_group_label>Cohort 1f</arm_group_label>
    <arm_group_label>Cohort 2d</arm_group_label>
    <arm_group_label>Cohort 2e</arm_group_label>
    <arm_group_label>Cohort 2f</arm_group_label>
    <arm_group_label>Cohort 3d</arm_group_label>
    <arm_group_label>Cohort 3e</arm_group_label>
    <arm_group_label>Cohort 3f</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pegylated interferon-alfa 2a</intervention_name>
    <description>pegylated interferon-alfa 2a given by subcutaneous injection</description>
    <arm_group_label>Cohort 1f</arm_group_label>
    <arm_group_label>Cohort 2d</arm_group_label>
    <arm_group_label>Cohort 2e</arm_group_label>
    <arm_group_label>Cohort 2f</arm_group_label>
    <arm_group_label>Cohort 3d</arm_group_label>
    <arm_group_label>Cohort 3e</arm_group_label>
    <arm_group_label>Cohort 3f</arm_group_label>
    <other_name>pegylated interferon alpha-2a</other_name>
    <other_name>PEG-IFNα</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female of ages 18 - 65&#xD;
&#xD;
          -  Chronic HBV infection for &gt;/= 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant chronic or acute medical condition that makes the volunteer&#xD;
             unsuitable for participation&#xD;
&#xD;
          -  Significant 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;
          -  Any prior receipt of an interferon product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Birtinya</city>
        <state>Queensland</state>
        <zip>4575</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Chuncheon</city>
        <zip>24253</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Daegu</city>
        <zip>41944</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Batu Caves</city>
        <zip>68100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Kajang</city>
        <zip>43000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Kuantan</city>
        <zip>25100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10700</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Chiang Mai</city>
        <zip>50200</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Hat Yai</city>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Khlong Luang</city>
        <zip>12120</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>New Zealand</country>
    <country>Thailand</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatitis B Virus</keyword>
  <keyword>Chronic Hepatitis B</keyword>
  <keyword>HBV</keyword>
  <keyword>Hepatitis</keyword>
  <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>
    <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>
    <mesh_term>Interferon alpha-2</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04412863
org study id: VIR-2218-1001-PEG-IFNα
nct id: NCT04412863
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a phase 2 study in which subjects with chronic hepatitis B virus (HBV) infection will
      receive VIR-2218 alone or in combination with pegylated interferon alfa-2a and will be
      assessed for safety, tolerability, pharmacokinetics, and antiviral activity.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with Adverse Events as assessed by CTCAE v5.0
time frame: Up to 148 Weeks
measure: Number of subjects with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
time frame: Up to 148 Weeks
measure: Mean maximum reduction of serum HBsAg at any timepoint
time frame: Up to 144 Weeks
measure: Number of subjects with serum HBsAg loss (undetectable HBsAg) at any timepoint
time frame: Up to 144 Weeks
measure: Number of subjects with sustained serum HBsAg loss (undetectable HBsAg) for greater than 6 months
time frame: Up to 144 Weeks
measure: Number of subjects with anti-HBs seroconversion at any timepoint
time frame: Up to 144 Weeks
measure: For HBeAg-positive subjects: number of subjects with HBeAg loss (undetectable HBeAg) and/or anti-HBe seroconversion at any timepoint
time frame: Up to 96 weeks
arm group label: Cohort 1d
arm group type: Experimental
description: VIR-2218 given by subcutaneous injection
arm group label: Cohort 2d
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 3d
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 1e
arm group type: Experimental
description: VIR-2218 given by subcutaneous injection
arm group label: Cohort 2e
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 3e
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 1f
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 2f
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 3f
arm group type: Experimental
description: VIR-2218 and pegylated interferon-alfa 2a given by subcutaneous injection
intervention type: Drug
intervention name: VIR-2218
description: VIR-2218 given by subcutaneous injection
arm group label: Cohort 1d
arm group label: Cohort 1e
arm group label: Cohort 1f
arm group label: Cohort 2d
arm group label: Cohort 2e
arm group label: Cohort 2f
arm group label: Cohort 3d
arm group label: Cohort 3e
arm group label: Cohort 3f
intervention type: Drug
intervention name: pegylated interferon-alfa 2a
description: pegylated interferon-alfa 2a given by subcutaneous injection
arm group label: Cohort 1f
arm group label: Cohort 2d
arm group label: Cohort 2e
arm group label: Cohort 2f
arm group label: Cohort 3d
arm group label: Cohort 3e
arm group label: Cohort 3f
other name: pegylated interferon alpha-2a
other name: PEG-IFNα
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
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country: Australia
country: Hong Kong
country: Korea, Republic of
country: Malaysia
country: New Zealand
country: Thailand
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Interferons
mesh term: Interferon-alpha
mesh term: Interferon alpha-2
mesh term: Peginterferon alfa-2a
sharing ipd: No