<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/NCT04465916</url>
  </required_header>
  <id_info>
    <org_study_id>EYP001-201</org_study_id>
    <nct_id>NCT04465916</nct_id>
  </id_info>
  <brief_title>Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)</brief_title>
  <official_title>A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enyo Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novotech (Australia) Pty Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Synteract, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eurofins</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Enyo Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a&#xD;
      experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically&#xD;
      suppressed CHB patients to improve functional cure rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 49 eligible patients will be enrolled and randomized at approximately 14 study&#xD;
      sites. Patients will be randomized prior to study drug (EYP001a or placebo and NA)&#xD;
      administration on Day 1 in the ratio of 3:1 into 2 arms:&#xD;
&#xD;
        -  Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)&#xD;
&#xD;
        -  Control Arm: Placebo + NA daily (12 patients)&#xD;
&#xD;
      The maximum total engagement duration for eligible patients in this study is up to 370 days:&#xD;
      90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up.&#xD;
&#xD;
      Patients enrolled in the study will be assessed as outpatients. Patient screening will occur&#xD;
      no more than 90 days prior to the Day 1 visit. Eligible patients will undergo further&#xD;
      assessments on Day 1 to qualify for study drug administration on Day 1.&#xD;
&#xD;
      The visits during the study are planned as below:&#xD;
&#xD;
        -  Screening visit: 12 weeks (90 days)&#xD;
&#xD;
        -  16 weeks treatment period:&#xD;
&#xD;
        -  Treatment Visit 1 (Week 1 [Day 1])&#xD;
&#xD;
        -  Treatment Visit 2 (Week 2 [Day 14 ±3 days])&#xD;
&#xD;
        -  Treatment Visit 3 (Week 4 [Day 28 ±3 days])&#xD;
&#xD;
        -  Treatment Visit 4 (Week 6 [Day 42 ±3 days])&#xD;
&#xD;
        -  Treatment Visit 5 (Week 8 [Day 56 ±3 days])&#xD;
&#xD;
        -  Treatment Visit 6 (Week 10 [Day 70 ± 3 days])&#xD;
&#xD;
        -  Treatment Visit 7 (Week 12 [Day 84 ± 3 days])&#xD;
&#xD;
        -  Treatment Visit 8 (Week 14 [Day 98 ± 3 days])&#xD;
&#xD;
        -  Treatment Visit 9 (Week 16 [Day 112±3 days])&#xD;
&#xD;
        -  24 weeks safety follow-up period:&#xD;
&#xD;
        -  Follow-up Visit 1 (Week 20 [Day 140 ±7 days])&#xD;
&#xD;
        -  Follow-up Visit 2 (Week 28 [Day 196 ±7 days])&#xD;
&#xD;
        -  Follow-up Visit 3 (Week 40 [Day 280 ±7 days]) Note: during follow-up patients are kept&#xD;
           on NA until the end of the trial: Week 40 (consolidation Phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized&#xD;
    subjects were followed up to W40.&#xD;
  </why_stopped>
  <start_date type="Actual">May 12, 2020</start_date>
  <completion_date type="Actual">November 25, 2021</completion_date>
  <primary_completion_date type="Actual">June 17, 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>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Triple blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment</measure>
    <time_frame>LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)</time_frame>
    <description>Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Virologic Failure Rate</measure>
    <time_frame>40 weeks</time_frame>
    <description>Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Hepatitis B, Chronic</condition>
  <arm_group>
    <arm_group_label>Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control Arm: Placebo + NA daily (12 patients)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EYP001a</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Control Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nucleotide analogue (Entecavir or Tenofovir Disoproxil)</intervention_name>
    <description>Oral tablets</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Experimental Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          -  Are on stable NA therapy at least 12 months from the screening date (ETV or TDF)&#xD;
&#xD;
          -  Has virally suppressed CHB:&#xD;
&#xD;
        HBV DNA &lt;LLOQ and serum HBsAg &gt;100 IU/mL&#xD;
&#xD;
          -  Has liver imaging to screen for hepatocellular carcinoma or concomitant&#xD;
             pancreaticobiliary disease either in the prior 6 months or at screening.&#xD;
&#xD;
          -  Is not of childbearing potential or, if of childbearing potential, is not pregnant as&#xD;
             confirmed by a negative serum human chorionic gonadotropin test at screening and is&#xD;
             not planning a pregnancy during the course of the study.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          -  Is an employee of a contract research organization (CRO), vendor, or Sponsor involved&#xD;
             with this study.&#xD;
&#xD;
          -  Has known hepatocellular carcinoma or pancreaticobiliary disease.&#xD;
&#xD;
          -  Neutropenia (defined by two confirmed values within screening period of &lt;1500/μL).&#xD;
&#xD;
          -  Has Gilbert syndrome.&#xD;
&#xD;
          -  Shows evidence of worsening liver function, defined as either a confirmed (two&#xD;
             assessments at least 3 days apart) increase &gt;2 ULN ALT or AST or an increase of &gt;1.5 ×&#xD;
             first assessed value of TBL or associated with clinical signs or symptoms of liver&#xD;
             impairment.&#xD;
&#xD;
          -  Has known or suspected non-CHB liver disease&#xD;
&#xD;
          -  History of cirrhosis or liver decompensation, including ascites, hepatic&#xD;
             encephalopathy, or presence of oesophageal varices.&#xD;
&#xD;
          -  Probable or possible F3 stage with a vibration controlled transient elastography&#xD;
             (VCTE). Patients with normal baseline ALT and VCTE &gt;8.8 kPa are excluded. Patients&#xD;
             with baseline ALT &gt;ULN (but &lt;2ULN per EC5) and who have VCTE &gt;10.5 kPa at baseline are&#xD;
             excluded 11.&#xD;
&#xD;
          -  Has known history of alcohol abuse or daily heavy alcohol consumption&#xD;
&#xD;
          -  Has clinically relevant immunosuppression, including, but not limited to,&#xD;
             immunodeficiency conditions such as common variable hypogammaglobulinemia.&#xD;
&#xD;
          -  Has used anti-HBV medications other than NAs within 90 days prior to screening.&#xD;
&#xD;
          -  Has any of the following exclusionary laboratory results at screening:&#xD;
&#xD;
               1. Estimated glomerular filtration rate &lt;60 mL/min/1.73 m2 (the Modification of Diet&#xD;
                  in Renal Disease formula).&#xD;
&#xD;
               2. Thyroid-stimulating hormone &gt;1.5× ULN or abnormal free triiodothyronine or free&#xD;
                  thyroxine.&#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>ENYO PHARMA Investigative site KR04</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR03</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR02</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR01</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL06</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kielce, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL05</last_name>
    <role>Principal Investigator</role>
    <affiliation>Łódź, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL04</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zawiercie, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL03</last_name>
    <role>Principal Investigator</role>
    <affiliation>Warszawa, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL02</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lublin, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site PL01</last_name>
    <role>Principal Investigator</role>
    <affiliation>Białystok, Poland</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site AU04</last_name>
    <role>Principal Investigator</role>
    <affiliation>Melbourne, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site AU03</last_name>
    <role>Principal Investigator</role>
    <affiliation>Melbourne, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site AU02</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brisbane, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site AU01</last_name>
    <role>Principal Investigator</role>
    <affiliation>Melbourne, Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site HK01</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hong Kong, Hong Kong</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR05</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seongnam, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR06</last_name>
    <role>Principal Investigator</role>
    <affiliation>Séoul, South Korea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ENYO PHARMA Investigative site KR07</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan, South Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site AU02</name>
      <address>
        <city>Brisbane</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site AU01</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site AU03</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site AU04</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site HK01</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR04</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR07</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR05</name>
      <address>
        <city>Seongnam</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR01</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR02</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR03</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site KR06</name>
      <address>
        <city>Séoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL01</name>
      <address>
        <city>Białystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL06</name>
      <address>
        <city>Kielce</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL02</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL03</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL04</name>
      <address>
        <city>Zawiercie</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ENYO PHARMA Investigative site PL05</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Hong Kong</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <results_first_submitted>August 22, 2022</results_first_submitted>
  <results_first_submitted_qc>September 21, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 12, 2022</results_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</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 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>Tenofovir</mesh_term>
    <mesh_term>Entecavir</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT04465916/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 13, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT04465916/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Arm</title>
          <description>Experimental Arm: EYP001a 200 mg daily + Nucleotide analogue daily (37 patients)&#xD;
EYP001a: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Control Arm: Placebo daily + Nucleotide analogue daily (12 patients)&#xD;
Placebo: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental Arm</title>
          <description>Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)&#xD;
EYP001a: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Control Arm: Placebo + NA daily (12 patients)&#xD;
Placebo: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.16" spread="8.32"/>
                    <measurement group_id="B2" value="46.29" spread="8.46"/>
                    <measurement group_id="B3" value="45.46" spread="8.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.821" spread="11.293"/>
                    <measurement group_id="B2" value="82.857" spread="21.084"/>
                    <measurement group_id="B3" value="72.600" spread="15.454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Geometric Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168.763" spread="9.333"/>
                    <measurement group_id="B2" value="172.529" spread="11.342"/>
                    <measurement group_id="B3" value="169.777" spread="9.823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment</title>
        <description>Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment</description>
        <time_frame>LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)&#xD;
EYP001a: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Control Arm: Placebo + NA daily (12 patients)&#xD;
Placebo: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment</title>
          <description>Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment</description>
          <units>log10 IU/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.029" spread="0.0195"/>
                    <measurement group_id="O2" value="-0.066" spread="0.0348"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Virologic Failure Rate</title>
        <description>Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period</description>
        <time_frame>40 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Arm</title>
            <description>Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)&#xD;
EYP001a: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Control Arm: Placebo + NA daily (12 patients)&#xD;
Placebo: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
          </group>
        </group_list>
        <measure>
          <title>Virologic Failure Rate</title>
          <description>Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 40</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>After the first dose of study drug until W40</time_frame>
      <desc>Participants received either Entecavir or Tenofovir Disoproxil Fumarate in each Arm/Group combined with Placebo or EYP001.&#xD;
Entecavir and Tenofovir Disoproxil Fumarate are both NA and are therapeutically equivalent.&#xD;
Therefore safety results are presented for Experimental Arm and Control Arm irrespective of NA therapy taken.</desc>
      <group_list>
        <group group_id="E1">
          <title>Experimental Arm</title>
          <description>Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)&#xD;
EYP001a: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Control Arm: Placebo + NA daily (12 patients)&#xD;
Placebo: Oral tablets&#xD;
Nucleotide analogue (Entecavir or Tenofovir Disoproxil): Oral tablets</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block first degree</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vaccination site discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The data may be considered for publication in a scientific journal or for reporting at a scientific meeting. Each Investigator is obligated to keep data pertaining to the study confidential. The Investigator must consult with the Sponsor before any study data are submitted for publication. The Sponsor reserves the right to deny publication rights until mutual agreement on the content, format, interpretation of data in the manuscript, and journal selected for publication are achieved.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pietro Scalfaro</name_or_title>
      <organization>ENYO Pharma SA</organization>
      <phone>+33437700219</phone>
      <email>ps@enyopharma.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04465916
org study id: EYP001-201
nct id: NCT04465916
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a prospective, multi-centre, randomized, double-blind, placebo-controlled, Phase 2a
      experimental study of oral FXR modulator EYP001a/placebo combined with NAs in virologically
      suppressed CHB patients to improve functional cure rates.
A total of 49 eligible patients will be enrolled and randomized at approximately 14 study
      sites. Patients will be randomized prior to study drug (EYP001a or placebo and NA)
      administration on Day 1 in the ratio of 3:1 into 2 arms:

        -  Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)

        -  Control Arm: Placebo + NA daily (12 patients)

      The maximum total engagement duration for eligible patients in this study is up to 370 days:
      90 days screening, 112 days (16 weeks) treatment period and 168 days (24 weeks) follow-up.

      Patients enrolled in the study will be assessed as outpatients. Patient screening will occur
      no more than 90 days prior to the Day 1 visit. Eligible patients will undergo further
      assessments on Day 1 to qualify for study drug administration on Day 1.

      The visits during the study are planned as below:

        -  Screening visit: 12 weeks (90 days)

        -  16 weeks treatment period:

        -  Treatment Visit 1 (Week 1 [Day 1])

        -  Treatment Visit 2 (Week 2 [Day 14 ±3 days])

        -  Treatment Visit 3 (Week 4 [Day 28 ±3 days])

        -  Treatment Visit 4 (Week 6 [Day 42 ±3 days])

        -  Treatment Visit 5 (Week 8 [Day 56 ±3 days])

        -  Treatment Visit 6 (Week 10 [Day 70 ± 3 days])

        -  Treatment Visit 7 (Week 12 [Day 84 ± 3 days])

        -  Treatment Visit 8 (Week 14 [Day 98 ± 3 days])

        -  Treatment Visit 9 (Week 16 [Day 112±3 days])

        -  24 weeks safety follow-up period:

        -  Follow-up Visit 1 (Week 20 [Day 140 ±7 days])

        -  Follow-up Visit 2 (Week 28 [Day 196 ±7 days])

        -  Follow-up Visit 3 (Week 40 [Day 280 ±7 days]) Note: during follow-up patients are kept
           on NA until the end of the trial: Week 40 (consolidation Phase).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Triple blind
measure: HBsAg Change (Δ log10) From Day 1 to Week 16 of Treatment
time frame: LS mean at week 16 (Day 1, Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, and Week 16)
description: Efficacy of Vonafexor on top of NA assessed as HBsAg decline (Δ log10) from Day 1 to Week 16 of treatment
measure: Virologic Failure Rate
time frame: 40 weeks
description: Virologic failure rate (breakthrough)2 of HBV-DNA (% patients with a confirmed quantifiable HBV DNA increase of ≥ 1log10 HBV DNA copies/mL above LLOQ3) assessed at Week 16 of treatment period and Weeks 20, 28 and 40 during follow-up period
arm group label: Experimental Arm
arm group type: Experimental
description: Experimental Arm: EYP001a Dose A QD + NA daily (37 patients)
arm group label: Control Arm
arm group type: Placebo Comparator
description: Control Arm: Placebo + NA daily (12 patients)
intervention type: Drug
intervention name: EYP001a
description: Oral tablets
arm group label: Experimental Arm
intervention type: Drug
intervention name: Placebo
description: Oral tablets
arm group label: Control Arm
intervention type: Drug
intervention name: Nucleotide analogue (Entecavir or Tenofovir Disoproxil)
description: Oral tablets
arm group label: Control Arm
arm group label: Experimental Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: ENYO PHARMA Investigative site KR04
role: Principal Investigator
affiliation: Pusan, South Korea
last name: ENYO PHARMA Investigative site KR03
role: Principal Investigator
affiliation: Seoul, South Korea
last name: ENYO PHARMA Investigative site KR02
role: Principal Investigator
affiliation: Seoul, South Korea
last name: ENYO PHARMA Investigative site KR01
role: Principal Investigator
affiliation: Seoul, South Korea
last name: ENYO PHARMA Investigative site PL06
role: Principal Investigator
affiliation: Kielce, Poland
last name: ENYO PHARMA Investigative site PL05
role: Principal Investigator
affiliation: Łódź, Poland
last name: ENYO PHARMA Investigative site PL04
role: Principal Investigator
affiliation: Zawiercie, Poland
last name: ENYO PHARMA Investigative site PL03
role: Principal Investigator
affiliation: Warszawa, Poland
last name: ENYO PHARMA Investigative site PL02
role: Principal Investigator
affiliation: Lublin, Poland
last name: ENYO PHARMA Investigative site PL01
role: Principal Investigator
affiliation: Białystok, Poland
last name: ENYO PHARMA Investigative site AU04
role: Principal Investigator
affiliation: Melbourne, Australia
last name: ENYO PHARMA Investigative site AU03
role: Principal Investigator
affiliation: Melbourne, Australia
last name: ENYO PHARMA Investigative site AU02
role: Principal Investigator
affiliation: Brisbane, Australia
last name: ENYO PHARMA Investigative site AU01
role: Principal Investigator
affiliation: Melbourne, Australia
last name: ENYO PHARMA Investigative site HK01
role: Principal Investigator
affiliation: Hong Kong, Hong Kong
last name: ENYO PHARMA Investigative site KR05
role: Principal Investigator
affiliation: Seongnam, South Korea
last name: ENYO PHARMA Investigative site KR06
role: Principal Investigator
affiliation: Séoul, South Korea
last name: ENYO PHARMA Investigative site KR07
role: Principal Investigator
affiliation: Pusan, South Korea
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country: Australia
country: Hong Kong
country: Korea, Republic of
country: Poland
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Entecavir
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