<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/NCT03780543</url>
  </required_header>
  <id_info>
    <org_study_id>ABI-H0731-211</org_study_id>
    <nct_id>NCT03780543</nct_id>
  </id_info>
  <brief_title>A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients</brief_title>
  <official_title>A Multi-center, Open-label, Long-term Extension Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients</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>
      Open-label, extension study to evaluate the safety and efficacy of combination therapy and&#xD;
      its effect on sustained viral response biomarkers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and&#xD;
      ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to&#xD;
      100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect&#xD;
      on biomarkers of sustained viral response (SVR) (NCT03780543).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision&#xD;
  </why_stopped>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">April 26, 2021</completion_date>
  <primary_completion_date type="Actual">April 26, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sustained Viral Response (SVR) at 24 Weeks Off Treatment</measure>
    <time_frame>Completing from week 52 until week 76</time_frame>
    <description>To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.&#xD;
SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Adverse Events</measure>
    <time_frame>Up to Week 148</time_frame>
    <description>Incidence of treatment emergent adverse events (AEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)</measure>
    <time_frame>EOT: up to Week 52 or 148; EOS: up to 3 years off treatment</time_frame>
    <description>To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)&#xD;
To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</measure>
    <time_frame>upto Week 148</time_frame>
    <description>Incidence of subjects with suppression/loss of viral Hepatitis B &quot;e&quot; antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</measure>
    <time_frame>Up to Week 148</time_frame>
    <description>Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>HBeAg-negative Subjects from Parent Study ABI-H0731-201</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care (SOC) nucleos(t)ide (NrtI)-suppressed and HBeAg-negative will receive both ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HBeAg-positive Subjects from Parent Study ABI-H0731-201</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.&#xD;
Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years.&#xD;
Subjects with insufficient virologic response will discontinue ABI-H0731 only and continue on SOC NrtI alone and followed-up for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects from Parent Study ABI-H0731-202</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.&#xD;
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148.&#xD;
Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up for up to 3 years. Subjects with insufficient virologic response at Week 148, will discontinue ABI-H0731 only and continue on SOC NrtI alone for up to 12 weeks.&#xD;
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731only and continue on SOC NrtI alone and enter follow-up for up to 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)</intervention_name>
    <description>Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert.</description>
    <arm_group_label>HBeAg-negative Subjects from Parent Study ABI-H0731-201</arm_group_label>
    <arm_group_label>HBeAg-positive Subjects from Parent Study ABI-H0731-201</arm_group_label>
    <arm_group_label>Subjects from Parent Study ABI-H0731-202</arm_group_label>
    <other_name>Entecavir (ETV) - brand name Baraclude</other_name>
    <other_name>Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread</other_name>
    <other_name>Tenofovir Alafenamide (TAF) - brand name: Descovy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to provide informed consent.&#xD;
&#xD;
          2. Previously enrolled on Study ABI-H0731-201 (NCT03576066) or ABI-H0731-202&#xD;
             (NCT03577171) and completed the treatment period, with demonstrated compliance in the&#xD;
             opinion of the investigator.&#xD;
&#xD;
          3. Female subjects must agree to use an effective birth control method for the duration&#xD;
             of the study and follow-up, or be surgically sterile for at least 6 months, or at&#xD;
             least 2 years postmenopausal with serum follicle-stimulating hormone (FSH) levels&#xD;
             consistent with a postmenopausal status. Effective birth control methods include male&#xD;
             or female condom (may not be used together due to increased risk of breakage),&#xD;
             vasectomy, intrauterine device (IUD), diaphragm, or cervical cap. Female subjects of&#xD;
             childbearing potential must have a negative serum pregnancy test.&#xD;
&#xD;
          4. All heterosexually active male subjects must agree to use an effective birth control&#xD;
             method for the duration of the study and follow-up. Effective birth control methods&#xD;
             include male or female condom (may not be used together due to increased risk of&#xD;
             breakage), vasectomy, hormone-based contraception (only female partner of a male&#xD;
             subject), IUD, diaphragm, or cervical cap.&#xD;
&#xD;
          5. Agreement to adhere to Lifestyle Considerations (including abstaining from alcohol&#xD;
             abuse [defined as alcohol consumption exceeding 2 standard drinks per day on average&#xD;
             (1 standard drink = 10 grams of alcohol)] and the use of illicit substances, herbal or&#xD;
             other substances, or unnecessary over-the-counter medications throughout study&#xD;
             duration.&#xD;
&#xD;
          6. In good general health except for chronic HBV infection.&#xD;
&#xD;
          7. Have the ability to take oral medication and be willing to adhere to the ABI-H0731-211&#xD;
             regimen in the opinion of the Investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Must not have had evidence of HBV resistance-associated variants (RAVs) or lack of&#xD;
             compliance on a previous study of ABI H0731.&#xD;
&#xD;
          2. Must not have had a treatment-emergent adverse event or laboratory abnormalities&#xD;
             deemed clinically significant and possibly or probably related to drug while on a&#xD;
             previous study of ABI-H0731, that in the opinion of the Investigator or the Sponsor&#xD;
             makes the subject unsuitable for this study.&#xD;
&#xD;
          3. Current clinically significant cardiac or pulmonary disease, chronic or recurrent&#xD;
             renal or urinary tract disease, liver disease other than HBV, endocrine disorder,&#xD;
             autoimmune disorder, diabetes mellitus requiring treatment with insulin or&#xD;
             hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions&#xD;
             requiring frequent treatment, seizure disorders requiring treatment, or other medical&#xD;
             conditions requiring frequent medical management or pharmacologic or surgical&#xD;
             treatment that in the opinion of the Investigator or the Sponsor makes the subject&#xD;
             unsuitable for the study.&#xD;
&#xD;
          4. Females who are lactating or pregnant or wish to become pregnant within the duration&#xD;
             of the ABI-H0731-211 study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>71 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michele Anderson</last_name>
    <role>Study Director</role>
    <affiliation>Assembly Biosciences Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>M. F. Yuen, MD, PhD, DSc</last_name>
    <role>Study Chair</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Research Center</name>
      <address>
        <city>Coronado</city>
        <state>California</state>
        <zip>92118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coalition of Inclusive Medicine</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</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>Medical Associates Research Group</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</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>Stanford University Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital and Clinics</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Digestive Disease Associates</name>
      <address>
        <city>Catonsville</city>
        <state>Maryland</state>
        <zip>21228</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>Sing Chan, MD</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xiaoli Ma, MD</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GI Research Institute</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6Z 2K5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto Liver Center</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6H 3M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hong Kong, 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>Auckland</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Hong Kong</country>
    <country>New Zealand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <results_first_submitted>December 23, 2022</results_first_submitted>
  <results_first_submitted_qc>January 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 17, 2023</results_first_posted>
  <disposition_first_submitted>March 22, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>January 24, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 17, 2023</disposition_first_posted>
  <last_update_submitted>March 24, 2023</last_update_submitted>
  <last_update_submitted_qc>March 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CHB (chronic hepatitis B infection)</keyword>
  <keyword>HBV (hepatitis B virus)</keyword>
  <keyword>HBeAg positive (hepatitis B &quot;e&quot; antigen - positive)</keyword>
  <keyword>HBeAg negative (hepatitis B &quot;e&quot; antigen - negative)</keyword>
  <keyword>Hepatitis B (hepatitis B virus)</keyword>
  <keyword>Hepatitis B virus (HBV)</keyword>
  <keyword>SVR (sustained viral response)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hepatitis, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Entecavir</mesh_term>
    <mesh_term>Reverse Transcriptase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03780543/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03780543/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.&#xD;
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="P2">
          <title>Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="P3">
          <title>HBeAg Positive Participants From Parent Study ABI-H0731-202</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.&#xD;
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg quaque die (QD) of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir alafenamide (TAF) tablet QD orally as per approved 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="26"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="B2">
          <title>Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="B3">
          <title>HBeAg Positive Participants From Parent Study ABI-H0731-202</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.&#xD;
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="B4">
          <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="26"/>
            <count group_id="B2" value="43"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" spread="7.8"/>
                    <measurement group_id="B2" value="45" spread="11.7"/>
                    <measurement group_id="B3" value="36" spread="13.0"/>
                    <measurement group_id="B4" value="44" spread="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Number of Participants</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="52"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="80"/>
                  </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="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Number of Participants in each location.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>New Zealand</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 group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m 2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.38" spread="2.922"/>
                    <measurement group_id="B2" value="23.97" spread="3.583"/>
                    <measurement group_id="B3" value="23.47" spread="3.984"/>
                    <measurement group_id="B4" value="23.96" spread="3.496"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Sustained Viral Response (SVR) at 24 Weeks Off Treatment</title>
        <description>To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.&#xD;
SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.</description>
        <time_frame>Completing from week 52 until week 76</time_frame>
        <population>Participants who met the protocol-specific treatment action criteria to discontinue treatment with ABI-H0731 and NrtI after completing 52 weeks of treatment were analyzed for sustained viral repones at 24 weeks off treatment. (i.e., Completing from week 52 (treatment discharge) until week 76 (24 weeks off treatment)</population>
        <group_list>
          <group group_id="O1">
            <title>Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201</title>
            <description>All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O2">
            <title>Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201</title>
            <description>Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O3">
            <title>Treatment-naïve Subjects With HBeAg Positive cHBV</title>
            <description>Treatment-naïve subjects with Hepatitis B &quot;e&quot; antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)</description>
          </group>
        </group_list>
        <measure>
          <title>Sustained Viral Response (SVR) at 24 Weeks Off Treatment</title>
          <description>To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.&#xD;
SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.</description>
          <population>Participants who met the protocol-specific treatment action criteria to discontinue treatment with ABI-H0731 and NrtI after completing 52 weeks of treatment were analyzed for sustained viral repones at 24 weeks off treatment. (i.e., Completing from week 52 (treatment discharge) until week 76 (24 weeks off treatment)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Adverse Events</title>
        <description>Incidence of treatment emergent adverse events (AEs)</description>
        <time_frame>Up to Week 148</time_frame>
        <population>Safety population included all who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201</title>
            <description>All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O2">
            <title>Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201</title>
            <description>Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O3">
            <title>Treatment-naïve Subjects With HBeAg Positive cHBV</title>
            <description>Treatment-naïve subjects with Hepatitis B &quot;e&quot; antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Adverse Events</title>
          <description>Incidence of treatment emergent adverse events (AEs)</description>
          <population>Safety population included all who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="43"/>
                <count group_id="O3" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of subjects with AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with discontinuation due to an AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of subjects with significant abnormal ECGs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)</title>
        <description>To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)&#xD;
To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS</description>
        <time_frame>EOT: up to Week 52 or 148; EOS: up to 3 years off treatment</time_frame>
        <population>Number/proportion of subjects with normal alanine aminotransferase (ALT) at end of treatment (EOT) and end of study (EOS)</population>
        <group_list>
          <group group_id="O1">
            <title>Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201</title>
            <description>All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O2">
            <title>Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201</title>
            <description>Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O3">
            <title>Treatment-naïve Subjects With HBeAg Positive cHBV</title>
            <description>Treatment-naïve subjects with Hepatitis B &quot;e&quot; antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from Study ABI-H0731-202 (Parent Study 202)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)</title>
          <description>To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)&#xD;
To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS</description>
          <population>Number/proportion of subjects with normal alanine aminotransferase (ALT) at end of treatment (EOT) and end of study (EOS)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Numbers with normal ALT levels at EOT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number with normal ALT levels at EOS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</title>
        <description>Incidence of subjects with suppression/loss of viral Hepatitis B &quot;e&quot; antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy</description>
        <time_frame>upto Week 148</time_frame>
        <population>The proportion of subjects with hepatitis B virus (HBV) DNA target not detected (TND).&#xD;
Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.</population>
        <group_list>
          <group group_id="O1">
            <title>Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201</title>
            <description>All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O2">
            <title>Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201</title>
            <description>Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O3">
            <title>Treatment-naïve Subjects With HBeAg Positive cHBV</title>
            <description>Treatment-naïve subjects with Hepatitis B &quot;e&quot; Ag antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from study ABI-H- (Parent Study 202)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</title>
          <description>Incidence of subjects with suppression/loss of viral Hepatitis B &quot;e&quot; antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy</description>
          <population>The proportion of subjects with hepatitis B virus (HBV) DNA target not detected (TND).&#xD;
Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</title>
        <description>Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment</description>
        <time_frame>Up to Week 148</time_frame>
        <population>Subjects from the parent study 201 with positive or negative Hepatitis B &quot;e&quot; antigen (HBeAg)&#xD;
Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.</population>
        <group_list>
          <group group_id="O1">
            <title>Virologically-suppressed HBeAg Negative Participants From Parent Study ABI-H0731-201</title>
            <description>All participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O2">
            <title>Virologically-suppressed HBeAg Positive Participants From Parent Study ABI-H0731-201</title>
            <description>Participants were treated with ABI-H0731 and NrtI for 52 weeks. Participants without virologic assessment at week 52 were evaluated at the next study visit.</description>
          </group>
          <group group_id="O3">
            <title>Treatment-naïve Subjects With HBeAG Positive cHBV</title>
            <description>Treatment-naïve subjects with Hepatitis B &quot;e&quot; Ag antigen (HBeAG) positive status with chronic hepatitis B virus (cHBV) from study ABI-H- (Parent Study 202)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy</title>
          <description>Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment</description>
          <population>Subjects from the parent study 201 with positive or negative Hepatitis B &quot;e&quot; antigen (HBeAg)&#xD;
Treatment-naïve Subjects With HBeAg Positive cHBV was not collected. No entry has been made in the column.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 148</time_frame>
      <desc>Clinical and laboratory adverse events (AEs) will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 21.0. System organ class (SOC), high-level group term (HLGT), high-level term (HLT), preferred term (PT), and lower-level term (LLT) will be provided in the AE dataset. AEs are graded by the Investigator as Grade 1, 2, 3, or 4 according to the toxicity criteria specified in the protocol.</desc>
      <group_list>
        <group group_id="E1">
          <title>Virologically Suppressed HBeAg-negative Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care nucleos(t)ide (SOC NrtI)-suppressed and HBeAg-negative will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="E2">
          <title>Virologically Suppressed HBeAg-positive Participants From Parent Study ABI-H0731-201</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated. Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years. Subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
        <group group_id="E3">
          <title>HBeAg Positive Participants From Parent Study ABI-H0731-202</title>
          <description>Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.&#xD;
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148. Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and be monitored for up to 3 years, while those subjects with insufficient virologic response will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731 and continue on SOC NrtI for 12 weeks.&#xD;
ABI-H0731: Participants will receive 300 mg QD of ABI-H0731 tablets orally.&#xD;
SOC NrtI: Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (21.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>fatique</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="43"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Development Officer</name_or_title>
      <organization>Assembly BioSciences Inc.</organization>
      <phone>415-855-3006</phone>
      <email>manderson@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/NCT03780543
org study id: ABI-H0731-211
nct id: NCT03780543
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Open-label, extension study to evaluate the safety and efficacy of combination therapy and
      its effect on sustained viral response biomarkers.
This is an open-label extension of parent studies ABI-H0731-201 (NCT03576066) and
      ABI-H0731-202 (NCT03577171). The extension study will assess the safety of long-term (up to
      100 weeks of treatment in extension study ABI-H0731-211) combination therapy and its effect
      on biomarkers of sustained viral response (SVR) (NCT03780543).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Sustained Viral Response (SVR) at 24 Weeks Off Treatment
time frame: Completing from week 52 until week 76
description: To evaluate the potential for combination therapy with ABI-H0731+ NrtI to increase SVR rates in subjects who have chronic hepatitis B (CHB). To evaluate the proportion of subjects who meet the definition of SVR at 24 weeks off treatment, the SVR rate and corresponding 95% confidence interval will be presented for the overall population while on combination therapy.
SVR is defined as sustained viral response with HBV DNA , LOQ (20 IU/mL) through off-treatment Week 24.
measure: Number of Subjects With Adverse Events
time frame: Up to Week 148
description: Incidence of treatment emergent adverse events (AEs)
measure: Number of Subjects With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at End of Treatment (EOT) and End of Study (EOS)
time frame: EOT: up to Week 52 or 148; EOS: up to 3 years off treatment
description: To measure the number and proportion of subjects with abnormal ALT at baseline who have normal ALT at end of treatment (EOT) and end of study (EOS)
To measure the number and proportion of subjects regardless of levels of ALT at baseline at EOT and EOS
measure: Number of Subjects With Suppression/Loss of Viral HBeAg Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
time frame: upto Week 148
description: Incidence of subjects with suppression/loss of viral Hepatitis B "e" antigen (HBeAg) antigen/DNA on combination treatment whose viral antigens rebound off therapy
measure: Number of Subjects With Suppression/Loss of Viral Core-related Antigen/DNA on Combination Treatment Whose Viral Antigens Rebound Off Therapy
time frame: Up to Week 148
description: Incidence of subjects with suppression/loss of viral core-related antigen (HBcrAg) or DNA on combination treatment whose viral antigens rebound off treatment
arm group label: HBeAg-negative Subjects from Parent Study ABI-H0731-201
arm group type: Active Comparator
description: Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were standard of care (SOC) nucleos(t)ide (NrtI)-suppressed and HBeAg-negative will receive both ABI-H0731 + SOC NrtI for at least 52 weeks, after which time they will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years.
arm group label: HBeAg-positive Subjects from Parent Study ABI-H0731-201
arm group type: Active Comparator
description: Subjects who on Day 1 of parent study ABI-H0731-201 (NCT03576066) were SOC NrtI-suppressed and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up (FU) for up to 3 years.
Subjects with insufficient virologic response will discontinue ABI-H0731 only and continue on SOC NrtI alone and followed-up for 12 weeks.
arm group label: Subjects from Parent Study ABI-H0731-202
arm group type: Active Comparator
description: Subjects who on Day 1 of parent study ABI-H0731-202 (NCT03577171) were treatment-naive and HBeAg-positive will receive ABI-H0731 + SOC NrtI for at least 52 weeks, after which time their viral response will be evaluated.
Subjects who meet the virologic response criteria at Week 52 will continue to receive ABI-H0731 + SOC NrtI for an additional 96 weeks, after which time their viral response will be evaluated at Week 148.
Subjects who meet the virologic response criteria at Week 148 will discontinue both ABI-H0731 and SOC NrtI and enter long-term off-treatment follow-up for up to 3 years. Subjects with insufficient virologic response at Week 148, will discontinue ABI-H0731 only and continue on SOC NrtI alone for up to 12 weeks.
Subjects with insufficient virologic response at Week 52 will discontinue from ABI-H0731only and continue on SOC NrtI alone and enter follow-up for up to 12 weeks.
intervention type: Drug
intervention name: standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
description: Participants will continue on their SOC NrtI, Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) or Tenofovir Alafenamide (TAF) tablet QD (once daily) orally as per approved package insert.
arm group label: HBeAg-negative Subjects from Parent Study ABI-H0731-201
arm group label: HBeAg-positive Subjects from Parent Study ABI-H0731-201
arm group label: Subjects from Parent Study ABI-H0731-202
other name: Entecavir (ETV) - brand name Baraclude
other name: Tenofovir Disoproxil Fumarate (TDF) - brand name: Viread
other name: Tenofovir Alafenamide (TAF) - brand name: Descovy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 71 Years
healthy volunteers: No
last name: Michele Anderson
role: Study Director
affiliation: Assembly Biosciences Inc.
last name: M. F. Yuen, MD, PhD, DSc
role: Study Chair
affiliation: The University of Hong Kong
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country: Canada
country: Hong Kong
country: New Zealand
country: United Kingdom
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: Tenofovir
mesh term: Entecavir
mesh term: Reverse Transcriptase Inhibitors
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 