<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/NCT04507269</url>
  </required_header>
  <id_info>
    <org_study_id>VIR-2218-1005</org_study_id>
    <nct_id>NCT04507269</nct_id>
  </id_info>
  <brief_title>Study of VIR-2218 in Patients With Chronic Hepatitis B in Mainland China</brief_title>
  <official_title>A Phase 2 Randomized, Placebo-Controlled Study in Mainland China to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-2218</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>
    <collaborator>
      <agency>Alnylam Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brii Biosciences Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 is to evaluate the safety, pharmacokinetics characteristics, and antiviral&#xD;
      activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland&#xD;
      China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>up to 48 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings</measure>
    <time_frame>up to 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>PK: maximum plasma concentration (ng/mL)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: time to reach maximum plasma concentration (h)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: area under the plasma concentration versus time curve (ng*h/mL)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: percent of area extrapolated from AUC last to infinity (%)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: apparent terminal elimination half-life (h)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: apparent plasma clearance (L/h)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PK: apparent volume of distribution (L)</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum reduction of serum HBsAg from baseline</measure>
    <time_frame>up to 16 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with serum HBsAg loss</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with sustained serum HBsAg loss for &gt;/= 6 months</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with anti-HBs seroconversion at any timepoint</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint</measure>
    <time_frame>up to 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>VIR-2218</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: VIR-2218 VIR-2218 given by subcutaneous injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Drug: Placebo Saline 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>VIR-2218</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline given by subcutaneous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 18 - 65;&#xD;
&#xD;
          -  Weight ≥ 40 kg to ≤ 125 kg;&#xD;
&#xD;
          -  Chronic HBV infection as defined by a positive serum HBsAg for ≥ 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;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yao Zhang, MD</last_name>
    <role>Study Director</role>
    <affiliation>Brii Biosciences Limited</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <disposition_first_submitted>July 26, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>July 26, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 28, 2022</disposition_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT04507269
org study id: VIR-2218-1005
nct id: NCT04507269
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is to evaluate the safety, pharmacokinetics characteristics, and antiviral
      activities of multiple doses of VIR-2218 in adults with chronic HBV infection in mainland
      China.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with treatment-emergent adverse events as assessed by CTCAE v5.0
time frame: up to 48 weeks
measure: Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings
time frame: up to 48 weeks
measure: PK: maximum plasma concentration (ng/mL)
time frame: up to 24 weeks
measure: PK: time to reach maximum plasma concentration (h)
time frame: up to 24 weeks
measure: PK: area under the plasma concentration versus time curve (ng*h/mL)
time frame: up to 24 weeks
measure: PK: percent of area extrapolated from AUC last to infinity (%)
time frame: up to 24 weeks
measure: PK: apparent terminal elimination half-life (h)
time frame: up to 24 weeks
measure: PK: apparent plasma clearance (L/h)
time frame: up to 24 weeks
measure: PK: apparent volume of distribution (L)
time frame: up to 24 weeks
measure: Maximum reduction of serum HBsAg from baseline
time frame: up to 16 weeks
measure: Number of subjects with serum HBsAg loss
time frame: up to 48 weeks
measure: Number of subjects with sustained serum HBsAg loss for >/= 6 months
time frame: up to 48 weeks
measure: Number of subjects with anti-HBs seroconversion at any timepoint
time frame: up to 48 weeks
measure: For HBeAg-positive subjects: Number of subjects with HBeAg loss and/or anti-HBe seroconversion at any timepoint
time frame: up to 48 weeks
arm group label: VIR-2218
arm group type: Experimental
description: Drug: VIR-2218 VIR-2218 given by subcutaneous injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Drug: Placebo Saline given by subcutaneous injection
intervention type: Drug
intervention name: VIR-2218
description: VIR-2218 given by subcutaneous injection
arm group label: VIR-2218
intervention type: Drug
intervention name: Placebo
description: Saline given by subcutaneous injection
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yao Zhang, MD
role: Study Director
affiliation: Brii Biosciences Limited
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
sharing ipd: No