<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/NCT04470388</url>
  </required_header>
  <id_info>
    <org_study_id>EDP 514-002</org_study_id>
    <nct_id>NCT04470388</nct_id>
  </id_info>
  <brief_title>A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment</brief_title>
  <official_title>A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enanta Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pharmaceutical Research Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Enanta Pharmaceuticals, Inc</source>
  <oversight_info>
    <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 randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B&#xD;
      subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28&#xD;
      Days treatment with EDP-514.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in&#xD;
      viremic chronic CHB-infected subjects not currently on treatment.&#xD;
&#xD;
      Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or&#xD;
      placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Actual">August 30, 2021</completion_date>
  <primary_completion_date type="Actual">August 30, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety measured by adverse events</measure>
    <time_frame>Up to 84 Days in HBV MAD Cohorts</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax of EDP-514</measure>
    <time_frame>Up to 28 Days in HBV MAD Cohorts</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of EDP-514</measure>
    <time_frame>Up to 28 Days in HBV MAD Cohorts</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in HBV DNA Viral Load Assay</measure>
    <time_frame>through Day 28 in HBV MAD Cohorts</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Chronic HBV Infection</condition>
  <arm_group>
    <arm_group_label>EDP-514 HBV MAD Cohorts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EDP-514 HBV MAD Placebo Cohort</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo, orally, once daily for 28 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EDP-514</intervention_name>
    <description>Oral Capsule</description>
    <arm_group_label>EDP-514 HBV MAD Cohorts</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo to match EDP-514</description>
    <arm_group_label>EDP-514 HBV MAD Placebo Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  An informed consent document signed and dated by the subject.&#xD;
&#xD;
          -  Healthy male and female subjects of any ethnic origin between the ages of 18 and 70&#xD;
             years, inclusive&#xD;
&#xD;
          -  HBV DNA levels:&#xD;
&#xD;
               -  For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in&#xD;
                  serum/plasma that is ≥20,000 IU/ml, or&#xD;
&#xD;
               -  For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in&#xD;
                  serum/plasma that is ≥2,000 IU/mL, and&#xD;
&#xD;
               -  For all subjects, no HBV DNA serum/plasma test values &lt;1,000 IU/ml over the&#xD;
                  previous 12 months (using an approved test)&#xD;
&#xD;
          -  CHB subjects must not have been on prescribed anti-HBV treatment for at least 12&#xD;
             months prior to Screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A documented prior diagnosis of cirrhosis&#xD;
&#xD;
          -  Pregnant or nursing females&#xD;
&#xD;
          -  Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV&#xD;
&#xD;
          -  Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Enanta Pharmaceuticals, Inc</last_name>
    <role>Study Director</role>
    <affiliation>Enanta Pharmaceuticals, Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>500209</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chia-Yi Christian Hospital</name>
      <address>
        <city>Chiayi</city>
        <zip>600566</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>500209</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>E-Da Hospital/E-DA Cancer Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>824410</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833401</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404332</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>704302</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100229</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch</name>
      <address>
        <city>Taoyuan</city>
        <zip>333423</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Ascending Dose</keyword>
  <keyword>hepatitis B virus</keyword>
  <keyword>HBV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT04470388
org study id: EDP 514-002
nct id: NCT04470388
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B
      subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28
      Days treatment with EDP-514.
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in
      viremic chronic CHB-infected subjects not currently on treatment.

      Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or
      placebo.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety measured by adverse events
time frame: Up to 84 Days in HBV MAD Cohorts
measure: Cmax of EDP-514
time frame: Up to 28 Days in HBV MAD Cohorts
measure: AUC of EDP-514
time frame: Up to 28 Days in HBV MAD Cohorts
measure: Change from baseline in HBV DNA Viral Load Assay
time frame: through Day 28 in HBV MAD Cohorts
arm group label: EDP-514 HBV MAD Cohorts
arm group type: Experimental
description: EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
arm group label: EDP-514 HBV MAD Placebo Cohort
arm group type: Placebo Comparator
description: Matching placebo, orally, once daily for 28 days.
intervention type: Drug
intervention name: EDP-514
description: Oral Capsule
arm group label: EDP-514 HBV MAD Cohorts
intervention type: Drug
intervention name: Placebo
description: Placebo to match EDP-514
arm group label: EDP-514 HBV MAD Placebo Cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Enanta Pharmaceuticals, Inc
role: Study Director
affiliation: Enanta Pharmaceuticals, Inc
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
country: Taiwan
responsible party type: Sponsor
mesh term: Infections
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis