<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/NCT04454567</url>
  </required_header>
  <id_info>
    <org_study_id>ABI-H0731-205</org_study_id>
    <secondary_id>UTN 1111-1251-7136</secondary_id>
    <nct_id>NCT04454567</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors</brief_title>
  <official_title>A Phase 2a, Multi-Center, Single-Blind, Placebo-Controlled Study Evaluating Treatment Intensification With ABI-H0731 in Subjects With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assembly Biosciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assembly Biosciences</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the safety and antiviral activity of ABI-H0731 when added to a&#xD;
      nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially&#xD;
      virologically suppressed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped due to a change in the Sponsor's overall development strategy from treatment of&#xD;
    chronic disease to finite, curative treatments, and is based partially on the advice and&#xD;
    feedback from experts and regulators.&#xD;
  </why_stopped>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Actual">April 8, 2021</completion_date>
  <primary_completion_date type="Actual">April 8, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With an Adverse Event</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Premature Discontinuation of Treatment</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Laboratory Abnormality</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With HBV DNA &lt;Lower Limit of Quantification (LLOQ) at Week 48</measure>
    <time_frame>Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in log10 HBV DNA</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HBV DNA &lt;LLOQ at Each Timepoint</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HBV DNA &lt;Limit of Detection (LOD)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With HBV pgRNA &lt;LLOQ</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Normalized Alanine Aminotransferase (ALT)</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of ABI-H0731</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Entecavir</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment</measure>
    <time_frame>Baseline and up to 5 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>ABI-H0731 + SOC NrtI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + SOC NrtI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABI-H0731</intervention_name>
    <description>Participants will receive ABI-H0731 tablets orally once daily</description>
    <arm_group_label>ABI-H0731 + SOC NrtI</arm_group_label>
    <arm_group_label>Placebo + SOC NrtI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo to ABI-H0731 tablets orally once daily</description>
    <arm_group_label>Placebo + SOC NrtI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NrtI</intervention_name>
    <description>Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
    <arm_group_label>ABI-H0731 + SOC NrtI</arm_group_label>
    <arm_group_label>Placebo + SOC NrtI</arm_group_label>
    <other_name>Nucleos(t)ide reverse transcriptase inhibitor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) 18 to 36 kg/m^2 and a minimum body weight of 45 kg (inclusive)&#xD;
&#xD;
          -  In good general health except for chronic hepatitis B (CHB)&#xD;
&#xD;
          -  HBeAg positive or HBeAg negative chronic hepatitis B&#xD;
&#xD;
          -  HBV DNA &gt;LLOQ using a commercially available assay with LLOQ=20 IU/mL&#xD;
&#xD;
          -  On a stable NrtI regimen (ETV, TDF or TAF) for more than 12 months&#xD;
&#xD;
          -  Lack of cirrhosis or advanced liver disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or prior treatment for CHB with lamivudine, telbivudine, adefovir, HBV core&#xD;
             inhibitor, or previous treatment with an investigational agent for HBV infection&#xD;
&#xD;
          -  Presence of substitutions in the HBV polymerase coding region which may confer reduced&#xD;
             susceptibility to NrtIs&#xD;
&#xD;
          -  Co-infection with human immunodeficiency virus, hepatitis A virus, hepatitis C virus,&#xD;
             hepatitis E virus, or hepatitis D virus&#xD;
&#xD;
          -  Females who are lactating or wish to become pregnant during the course of the trial&#xD;
&#xD;
          -  History or evidence of advanced liver disease or hepatic decompensation&#xD;
&#xD;
          -  Clinically significant cardiac disease including poorly-controlled or unstable&#xD;
             hypertension; pulmonary disease; chronic or recurrent renal or urinary tract disease;&#xD;
             liver disease other than CHB; endocrine disorder; autoimmune disorder; poorly&#xD;
             controlled diabetes mellitus; neuromuscular, musculoskeletal, or mucocutaneous&#xD;
             conditions requiring frequent treatment, seizure disorders requiring treatment;&#xD;
             ongoing infection or other medical conditions requiring frequent medical management or&#xD;
             pharmacologic or surgical treatment that, in the opinion of the Investigator or the&#xD;
             Sponsor, makes the subject unsuitable for trial participation&#xD;
&#xD;
          -  History of hepatocellular carcinoma (HCC)&#xD;
&#xD;
          -  Exclusionary laboratory parameters at Screening:&#xD;
&#xD;
               -  Platelet count &lt;100,000/mm^3&#xD;
&#xD;
               -  Albumin &lt;lower limit of normal&#xD;
&#xD;
               -  Total bilirubin &gt;1.2 × upper limit of normal (ULN)&#xD;
&#xD;
               -  Direct bilirubin &gt;1.2 × ULN&#xD;
&#xD;
               -  ALT &gt;10 × ULN&#xD;
&#xD;
               -  Serum alpha fetoprotein (AFP) ≥100 ng/mL. If AFP at Screening is &gt;ULN but &lt;100&#xD;
                  ng/mL, the participant is eligible if a hepatic imaging trial prior to initiation&#xD;
                  of study drug reveals no lesions indicative of possible HCC.&#xD;
&#xD;
               -  International Normalized Ratio &gt;1.5 × ULN&#xD;
&#xD;
               -  Glomerular filtration rate &lt;50 mL/min/1.73 m^2 by Chronic Kidney Disease&#xD;
                  Epidemiology Collaboration equation&#xD;
&#xD;
               -  Any other laboratory abnormality deemed clinically significant by the Sponsor or&#xD;
                  the Investigator.&#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>Steven Knox</last_name>
    <role>Study Director</role>
    <affiliation>Assembly Biosciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asia Pacific Liver Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Liver Research Institute</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research and Education</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quest Clinical Research</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schiff Center for Liver Disease</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Human Virology</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Disease Care</name>
      <address>
        <city>Hillsborough</city>
        <state>New Jersey</state>
        <zip>08844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of X.M., MD</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland Clinical Studies</name>
      <address>
        <city>Grafton</city>
        <state>Auckland</state>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>New Zealand</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <results_first_submitted>April 7, 2022</results_first_submitted>
  <results_first_submitted_qc>September 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 20, 2022</results_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 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 A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Reverse Transcriptase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT04454567/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ABI-H0731 + SOC NrtI</title>
          <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
        </group>
        <group group_id="P2">
          <title>Placebo + SOC NrtI</title>
          <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <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>ABI-H0731 + SOC NrtI</title>
          <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
        </group>
        <group group_id="B2">
          <title>Placebo + SOC NrtI</title>
          <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</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="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</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>Years positive for HBV</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.6"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="24.8" spread="28.567"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years on HBV treatment at Baseline</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.6"/>
                    <measurement group_id="B2" value="1.5"/>
                    <measurement group_id="B3" value="2.55" spread="1.485"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HBV DNA (Cobas log10 IU/mL)</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.20"/>
                    <measurement group_id="B2" value="2.06"/>
                    <measurement group_id="B3" value="2.13" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HBV pgRNA (log10 U/mL)</title>
          <units>log10 U/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.85"/>
                    <measurement group_id="B2" value="6.55"/>
                    <measurement group_id="B3" value="5.7" spread="1.202"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HBeAg (log10 IU/mL)</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.35"/>
                    <measurement group_id="B2" value="2.82"/>
                    <measurement group_id="B3" value="2.585" spread="0.332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HBcrAg (log10 kU/mL)</title>
          <units>log10 kU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.89"/>
                    <measurement group_id="B2" value="0.92"/>
                    <measurement group_id="B3" value="0.905" spread="0.021"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline HBsAg (log10 IU/mL)</title>
          <units>log10 IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.81"/>
                    <measurement group_id="B2" value="4.61"/>
                    <measurement group_id="B3" value="4.21" spread="0.566"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline ALT (U/L)</title>
          <units>U/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13.5" spread="3.536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With an Adverse Event</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Adverse Event</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Premature Discontinuation of Treatment</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Premature Discontinuation of Treatment</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Laboratory Abnormality</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Laboratory Abnormality</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With HBV DNA &lt;Lower Limit of Quantification (LLOQ) at Week 48</title>
        <time_frame>Week 48</time_frame>
        <population>Due to early termination of the study, data for Week 48 were not collected and analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HBV DNA &lt;Lower Limit of Quantification (LLOQ) at Week 48</title>
          <population>Due to early termination of the study, data for Week 48 were not collected and analyzed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in log10 HBV DNA</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not collected and analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in log10 HBV DNA</title>
          <population>Due to early termination of the study, data were not collected and analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HBV DNA &lt;LLOQ at Each Timepoint</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not available to analyze the secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HBV DNA &lt;LLOQ at Each Timepoint</title>
          <population>Due to early termination of the study, data were not available to analyze the secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HBV DNA &lt;Limit of Detection (LOD)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HBV DNA &lt;Limit of Detection (LOD)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With HBV pgRNA &lt;LLOQ</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With HBV pgRNA &lt;LLOQ</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Normalized Alanine Aminotransferase (ALT)</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Normalized Alanine Aminotransferase (ALT)</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of ABI-H0731</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of ABI-H0731</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Concentrations of Entecavir</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Concentrations of Entecavir</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment</title>
        <time_frame>Baseline and up to 5 months</time_frame>
        <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
        <group_list>
          <group group_id="O1">
            <title>ABI-H0731 + SOC NrtI</title>
            <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
          <group group_id="O2">
            <title>Placebo + SOC NrtI</title>
            <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment</title>
          <population>Due to early termination of the study, data were not analyzed for secondary outcomes.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline and up to 5 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ABI-H0731 + SOC NrtI</title>
          <description>Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</description>
        </group>
        <group group_id="E2">
          <title>Placebo + SOC NrtI</title>
          <description>Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.&#xD;
ABI-H0731: Participants will receive ABI-H0731 tablets orally once daily&#xD;
Placebo: Participants will receive placebo to ABI-H0731 tablets orally once daily&#xD;
NrtI: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <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="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <description>COVID-19 infection</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <description>Flu like symptoms secondary to COVID vaccine</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1"/>
              </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>Assembly Biosciences agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Assembly Biosciences supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study ABI-H0731-205 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. At the time of early termination, only 2 participants were enrolled, both of which discontinued their assigned study treatment early due to the study being terminated early by the Sponsor. As a result, the primary outcome of number of participants with HBV DNA &lt;LLOQ at Week 48 could not be assessed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Executive Director of Clinical Operations</name_or_title>
      <organization>Assembly Biosciences</organization>
      <phone>833-509-4583</phone>
      <email>Clinicaltrials@assemblybio.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/NCT04454567
org study id: ABI-H0731-205
secondary id: UTN 1111-1251-7136
nct id: NCT04454567
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study will explore the safety and antiviral activity of ABI-H0731 when added to a
      nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially
      virologically suppressed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With an Adverse Event
time frame: Baseline and up to 5 months
measure: Number of Participants With Premature Discontinuation of Treatment
time frame: Baseline and up to 5 months
measure: Number of Participants With a Laboratory Abnormality
time frame: Baseline and up to 5 months
measure: Number of Participants With HBV DNA <Lower Limit of Quantification (LLOQ) at Week 48
time frame: Week 48
measure: Mean Change From Baseline in log10 HBV DNA
time frame: Baseline and up to 5 months
measure: Number of Participants With HBV DNA <LLOQ at Each Timepoint
time frame: Baseline and up to 5 months
measure: Number of Participants With HBV DNA <Limit of Detection (LOD)
time frame: Baseline and up to 5 months
measure: Mean Change From Baseline in log10 HBV Pregenomic RNA (pgRNA)
time frame: Baseline and up to 5 months
measure: Number of Participants With HBV pgRNA <LLOQ
time frame: Baseline and up to 5 months
measure: Mean Change From Baseline in log10 Serum Hepatitis B 'e' Antigen (HBeAg)
time frame: Baseline and up to 5 months
measure: Mean Change From Baseline in log10 Serum Hepatitis B Core-related Antigen (HBcrAg)
time frame: Baseline and up to 5 months
measure: Mean Change From Baseline in log10 Serum Hepatitis B Surface Antigen (HBsAg)
time frame: Baseline and up to 5 months
measure: Number of Participants With Normalized Alanine Aminotransferase (ALT)
time frame: Baseline and up to 5 months
measure: Plasma Concentrations of ABI-H0731
time frame: Baseline and up to 5 months
measure: Plasma Concentrations of Entecavir
time frame: Baseline and up to 5 months
measure: Incidence of HBV Variants Among Participants With Evidence of Non-response to Treatment
time frame: Baseline and up to 5 months
arm group label: ABI-H0731 + SOC NrtI
arm group type: Experimental
description: Participants with chronic hepatitis B virus (HBV) infection with partial virologic suppression on NrtI alone will receive ABI-H0731 300 mg once daily plus standard of care (SOC) NrtI for 96 weeks, followed by SOC NrtI alone for an additional 24 weeks (120 weeks total).
arm group label: Placebo + SOC NrtI
arm group type: Placebo Comparator
description: Participants with chronic HBV infection with partial virologic suppression on NrtI alone will receive placebo to ABI-H0731 once daily plus SOC NrtI for 48 weeks, followed by ABI-H0731 300 mg once daily plus SOC NrtI for Weeks 48 to 96, followed by SOC NrtI alone for Weeks 96 to 120.
intervention type: Drug
intervention name: ABI-H0731
description: Participants will receive ABI-H0731 tablets orally once daily
arm group label: ABI-H0731 + SOC NrtI
arm group label: Placebo + SOC NrtI
intervention type: Drug
intervention name: Placebo
description: Participants will receive placebo to ABI-H0731 tablets orally once daily
arm group label: Placebo + SOC NrtI
intervention type: Drug
intervention name: NrtI
description: Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
arm group label: ABI-H0731 + SOC NrtI
arm group label: Placebo + SOC NrtI
other name: Nucleos(t)ide reverse transcriptase inhibitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Steven Knox
role: Study Director
affiliation: Assembly Biosciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
country: New Zealand
country: United States
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Reverse Transcriptase Inhibitors
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study ABI-H0731-205 was terminated early by the study Sponsor for strategic reasons to prioritize research and development efforts on finite and curative HBV therapies. At the time of early termination, only 2 participants were enrolled, both of which discontinued their assigned study treatment early due to the study being terminated early by the Sponsor. As a result, the primary outcome of number of participants with HBV DNA <LLOQ at Week 48 could not be assessed.
point of contact: 