<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/NCT04423393</url>
  </required_header>
  <id_info>
    <org_study_id>VIR-3434-1002</org_study_id>
    <secondary_id>2019-003837-40</secondary_id>
    <nct_id>NCT04423393</nct_id>
  </id_info>
  <brief_title>Study of VIR-3434 in Healthy Volunteers and Patients With Chronic Hepatitis B Virus Infection</brief_title>
  <official_title>A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of VIR-3434</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vir Biotechnology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vir Biotechnology, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</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 1 study in which healthy volunteers and participants with chronic HBV&#xD;
      infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability,&#xD;
      pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV&#xD;
      infection).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2020</start_date>
  <completion_date type="Actual">November 25, 2022</completion_date>
  <primary_completion_date type="Actual">October 24, 2022</primary_completion_date>
  <phase>Phase 1</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>Incidence of treatment-emergent adverse events (TEAEs)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment of changes in physical examinations</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in vital signs: blood pressure</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in vital signs: pulse rate</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in vital signs: temperature</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in vital signs: respiratory rate</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with abnormalities in ECGs</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in liver function tests</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and bilirubin</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in serum chemistry parameters</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>Albumin, blood urea nitrogen, calcium, carbon dioxide/bicarbonate, chloride, creatine kinase, creatinine, creatinine clearance, gamma glutamyl transferase, glucose, lactate dehydrogenase, potassium, and sodium</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in hematology parameters</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>Bands, basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, monocytes, neutrophils, platelets, red blood cells, and white blood cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in coagulation parameters</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>INR and prothrombin time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in urinalysis parameters</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>Bilirubin, glucose, ketones, leukocytes, nitrite, pH, proteins, red blood cells, specific gravity, and urobilinogen</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment and quantification of changes in complement</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
    <description>C3 and C4</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical assessment of changes in local tolerability using a numeric scoring tool that is based on FDA and DAIDs injection site reaction grading scales</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clast</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tlast</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>%AUCexp</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>λz</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz (IV only)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL (IV only)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F (SC only)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F (SC only)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of ADA to VIR-3434</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Titers of ADA to VIR-3434</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum reduction of serum HBsAg from baseline (Day 1 predose)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Part D only: maximum change of HBV DNA from baseline (Day 1 predose)</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Assessment of mean changes in HBV RNA levels</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Assessment of mean changes in HBcrAg levels</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Evaluation of host immune responses in peripheral blood, including analysis of circulating biomarkers and cellular immunity</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Analysis and evaluation of host gene expression by RNA-sequencing</measure>
    <time_frame>Up to 280 days post-dose</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Fc gamma receptor (FcγR) polymorphisms as determined by genotyping</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>IgG allotypes as determined by genotyping</measure>
    <time_frame>Day 1</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>VIR-3434</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VIR-3434</intervention_name>
    <description>VIR-3434 given by subcutaneous injection or intravenous infusion.</description>
    <arm_group_label>VIR-3434</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Healthy Volunteers:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 18 - 55&#xD;
&#xD;
          -  Weight 40-125 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant chronic or acute medical condition that makes the volunteer&#xD;
             unsuitable for participation&#xD;
&#xD;
          -  History or evidence of drug or alcohol abuse&#xD;
&#xD;
          -  History of allergic reactions to monoclonal antibodies or antibody fragments&#xD;
&#xD;
          -  History of anaphylaxis&#xD;
&#xD;
        CHB Patients:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female age 18 - 65&#xD;
&#xD;
          -  Weight 40-125 kg&#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&#xD;
             participant unsuitable for participation&#xD;
&#xD;
          -  Significant fibrosis or cirrhosis&#xD;
&#xD;
          -  History or evidence of drug or alcohol abuse&#xD;
&#xD;
          -  History of chronic liver disease from any cause other than chronic HBV infection&#xD;
&#xD;
          -  History of hepatic decompensation&#xD;
&#xD;
          -  History of anaphylaxis&#xD;
&#xD;
          -  History of allergic reactions to monoclonal antibodies or antibody fragments&#xD;
&#xD;
          -  History of immune complex disease&#xD;
&#xD;
          -  Active infection with HIV, HCV or hepatitis Delta virus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</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>47392</zip>
        <country>Korea, Republic of</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>Seoul</city>
        <zip>02841</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>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</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>Havelock North</city>
        <zip>4130</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Tauranga</city>
        <zip>3110</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>London</city>
        <zip>E1 1FR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M8 5RB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>New Zealand</country>
    <country>Romania</country>
    <country>Singapore</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</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>
  <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/NCT04423393
org study id: VIR-3434-1002
secondary id: 2019-003837-40
nct id: NCT04423393
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This is a Phase 1 study in which healthy volunteers and participants with chronic HBV
      infection will receive VIR-3434 or placebo and will be assessed for safety, tolerability,
      pharmacokinetics (PK), and antiviral activity (only in participants with chronic HBV
      infection).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of treatment-emergent adverse events (TEAEs)
time frame: Up to 280 days post-dose
measure: Clinical assessment of changes in physical examinations
time frame: Up to 280 days post-dose
measure: Clinical assessment and quantification of changes in vital signs: blood pressure
time frame: Up to 280 days post-dose
measure: Clinical assessment and quantification of changes in vital signs: pulse rate
time frame: Up to 280 days post-dose
measure: Clinical assessment and quantification of changes in vital signs: temperature
time frame: Up to 280 days post-dose
measure: Clinical assessment and quantification of changes in vital signs: respiratory rate
time frame: Up to 280 days post-dose
measure: Proportion of subjects with abnormalities in ECGs
time frame: Up to 280 days post-dose
measure: Clinical assessment and quantification of changes in liver function tests
time frame: Up to 280 days post-dose
description: Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and bilirubin
measure: Clinical assessment and quantification of changes in serum chemistry parameters
time frame: Up to 280 days post-dose
description: Albumin, blood urea nitrogen, calcium, carbon dioxide/bicarbonate, chloride, creatine kinase, creatinine, creatinine clearance, gamma glutamyl transferase, glucose, lactate dehydrogenase, potassium, and sodium
measure: Clinical assessment and quantification of changes in hematology parameters
time frame: Up to 280 days post-dose
description: Bands, basophils, eosinophils, hematocrit, hemoglobin, lymphocytes, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, monocytes, neutrophils, platelets, red blood cells, and white blood cells
measure: Clinical assessment and quantification of changes in coagulation parameters
time frame: Up to 280 days post-dose
description: INR and prothrombin time
measure: Clinical assessment and quantification of changes in urinalysis parameters
time frame: Up to 280 days post-dose
description: Bilirubin, glucose, ketones, leukocytes, nitrite, pH, proteins, red blood cells, specific gravity, and urobilinogen
measure: Clinical assessment and quantification of changes in complement
time frame: Up to 280 days post-dose
description: C3 and C4
measure: Clinical assessment of changes in local tolerability using a numeric scoring tool that is based on FDA and DAIDs injection site reaction grading scales
time frame: Up to 280 days post-dose
measure: Cmax
time frame: Up to 280 days post-dose
measure: Clast
time frame: Up to 280 days post-dose
measure: Tmax
time frame: Up to 280 days post-dose
measure: Tlast
time frame: Up to 280 days post-dose
measure: AUCinf
time frame: Up to 280 days post-dose
measure: AUClast
time frame: Up to 280 days post-dose
measure: %AUCexp
time frame: Up to 280 days post-dose
measure: t1/2
time frame: Up to 280 days post-dose
measure: λz
time frame: Up to 280 days post-dose
measure: Vz (IV only)
time frame: Up to 280 days post-dose
measure: CL (IV only)
time frame: Up to 280 days post-dose
measure: Vz/F (SC only)
time frame: Up to 280 days post-dose
measure: CL/F (SC only)
time frame: Up to 280 days post-dose
measure: Incidence of ADA to VIR-3434
time frame: Up to 280 days post-dose
measure: Titers of ADA to VIR-3434
time frame: Up to 280 days post-dose
measure: Maximum reduction of serum HBsAg from baseline (Day 1 predose)
time frame: Up to 280 days post-dose
measure: Part D only: maximum change of HBV DNA from baseline (Day 1 predose)
time frame: Up to 280 days post-dose
measure: Assessment of mean changes in HBV RNA levels
time frame: Up to 280 days post-dose
measure: Assessment of mean changes in HBcrAg levels
time frame: Up to 280 days post-dose
measure: Evaluation of host immune responses in peripheral blood, including analysis of circulating biomarkers and cellular immunity
time frame: Up to 280 days post-dose
measure: Analysis and evaluation of host gene expression by RNA-sequencing
time frame: Up to 280 days post-dose
measure: Fc gamma receptor (FcγR) polymorphisms as determined by genotyping
time frame: Day 1
measure: IgG allotypes as determined by genotyping
time frame: Day 1
arm group label: VIR-3434
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Biological
intervention name: VIR-3434
description: VIR-3434 given by subcutaneous injection or intravenous infusion.
arm group label: VIR-3434
intervention type: Other
intervention name: Placebo
description: Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Hong Kong
country: Korea, Republic of
country: New Zealand
country: Romania
country: Singapore
country: United Kingdom
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
sharing ipd: No