<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/NCT02249988</url>
  </required_header>
  <id_info>
    <org_study_id>ABX203-002</org_study_id>
    <nct_id>NCT02249988</nct_id>
  </id_info>
  <brief_title>Clinical Efficacy of ABX203 Therapeutic Vaccine in HBeAg Negative Patients With Chronic Hepatitis B</brief_title>
  <official_title>Phase IIB-III Efficacy Study of ABX203 Vaccine as an Adjunct Therapy to Nucleos(t)Ide Analogs to Maintain Control of HBV Replication After Cessation of Treatment in HBeAg Negative Patients With Chronic Hepatitis B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abivax S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abivax S.A.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose&#xD;
      of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic&#xD;
      vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining&#xD;
      control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg&#xD;
      negative chronic Hepatitis B.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of subjects with viral load &lt; 40 IU/mL at Week 48.</measure>
    <time_frame>Week 48</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical response defined as changes in viral load, liver function, time to relapse</measure>
    <time_frame>Week 48 and Week 96</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)</measure>
    <time_frame>Week 48</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs</measure>
    <time_frame>Participants will be followed for the duration of their study participation up to 96 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">261</enrollment>
  <condition>Chronic Hepatitis B</condition>
  <arm_group>
    <arm_group_label>Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ABX203 therapeutic vaccine in addition to NUCs background therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Control arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>NUCs background therapy only</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ABX203 therapeutic Hepatitis B vaccine treatment arm</intervention_name>
    <arm_group_label>Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subject between 18 and 65 years of age at the time of randomization.&#xD;
&#xD;
          -  Must be HBeAg negative and anti-HBe Abs positive for at least 1 year prior to&#xD;
             screening and at screening.&#xD;
&#xD;
          -  Has HBV DNA &lt; 40 IU/mL for at least 1 year prior to screening and at screening&#xD;
&#xD;
          -  Has both ALT and AST levels ≤ ULN for at least 1 year prior to screening and at&#xD;
             screening.&#xD;
&#xD;
          -  Must be HBsAg positive at screening.&#xD;
&#xD;
          -  Has been treated with NUCs for at least 2 years prior to screening.&#xD;
&#xD;
          -  Has not been treated with PEG-IFN or IFN for at least 1 year prior to screening.&#xD;
&#xD;
          -  For all females, must have a negative serum pregnancy test at screening. For female of&#xD;
             childbearing potential, must have been using adequate contraception and must agree to&#xD;
             continue to use it during all study period and for 6 months after completion of the&#xD;
             study product administration.&#xD;
&#xD;
          -  Has provided written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has elevated blood levels of alpha-fetoprotein (AFP) (&gt; 500 ng/mL).&#xD;
&#xD;
          -  Has cirrhosis, defined as&#xD;
&#xD;
               -  platelet count &lt; 150,000/mm3, with esophageal varices on imaging and spleen size&#xD;
                  &gt; 12, or&#xD;
&#xD;
               -  liver stiffness of 11 kilopascal [kPa] as measured by elastography using&#xD;
                  FibroScan® or .an AST to Platelet Ratio Index (APRI) &gt; 2).&#xD;
&#xD;
          -  Has hepatocellular carcinoma (HCC) (diagnosed by ultrasonography).&#xD;
&#xD;
          -  Has liver decompensation (albumin &lt; 3.5 g/dL and bilirubin ≥1.3 mg/dL).&#xD;
&#xD;
          -  Is Hepatitis C virus (HCV) Ab positive at screening.&#xD;
&#xD;
          -  Is Hepatitis delta virus (HDV) Ab positive at screening.&#xD;
&#xD;
          -  Is Human Immunodeficiency Virus (HIV) Ab positive at screening.&#xD;
&#xD;
          -  Has an immune suppressive disorder or treatment with immunosuppressive drugs.&#xD;
&#xD;
          -  Has been treated with corticosteroids within 12 weeks prior to the first&#xD;
             administration of study product, with the exception of topical or inhaled&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Has been treated with rituximab.&#xD;
&#xD;
          -  Has other hepatic diseases of different etiology (such as auto-immune hepatitis, toxic&#xD;
             hepatitis, Wilson disease, alcoholic or hemochromatosis).&#xD;
&#xD;
          -  Has a history of allergic disease or reactions likely to be exacerbated by any&#xD;
             component of the study products.&#xD;
&#xD;
          -  Has a history of a substance abuse (drug or alcohol) problem within the previous 3&#xD;
             years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Royal Prince Alfred Hospital</name>
      <address>
        <city>Camperdown</city>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre Clayton</name>
      <address>
        <city>Clayton</city>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Alfred Hospital</name>
      <address>
        <city>Melbourne</city>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waikato Hospital</name>
      <address>
        <city>Hamilton West</city>
        <zip>3240</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02249988
org study id: ABX203-002
nct id: NCT02249988
lead sponsor: 
has dmc: Yes
The study is an open-label, randomized, comparative, multicenter clinical trial. The purpose
      of this study is to assess the efficacy of ABX203, a new chronic hepatitis B therapeutic
      vaccine administered as an adjunct therapy to nucleos(t)ide analogs (NUCs), in maintaining
      control of Hepatitis B disease after cessation of treatment with NUCs in subjects with HBeAg
      negative chronic Hepatitis B.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects with viral load < 40 IU/mL at Week 48.
time frame: Week 48
measure: Clinical response defined as changes in viral load, liver function, time to relapse
time frame: Week 48 and Week 96
measure: Immune response defined as T-cell response by ICS (CD4 and CD8 to HBcAg and HBsAg)
time frame: Week 48
measure: Safety assessment will be conducted throughout the study and will include physical examinations, vital signs, clinical laboratory évaluations, and the recording of AEs
time frame: Participants will be followed for the duration of their study participation up to 96 weeks
arm group label: Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm
arm group type: Experimental
description: ABX203 therapeutic vaccine in addition to NUCs background therapy
arm group label: Group 2 - Control arm
arm group type: No Intervention
description: NUCs background therapy only
intervention type: Drug
intervention name: ABX203 therapeutic Hepatitis B vaccine treatment arm
arm group label: Group 1 - ABX203 therapeutic Hepatitis B vaccine treatment arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Australia
country: New Zealand
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic