xml: <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/NCT06000657</url>
    </required_header>
    <id_info>
      <org_study_id>DWVMLV_P401</org_study_id>
      <nct_id>NCT06000657</nct_id>
    </id_info>
    <brief_title>The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir</brief_title>
    <official_title>The Efficacy and Safety of Switching to Vemliver Tab (Tenofovir Alafenamide Hemitartrate) From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir; A Multi-Center, Randomized, Open-Label, Active-Controlled, Non-Inferiority, Phase IV Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Daewoong Pharmaceutical Co. LTD.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Daewoong Pharmaceutical Co. LTD.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV&#xD;
        antiviral (HBV DNA &lt;69 IU/mL) effects.&#xD;
  &#xD;
        Subjects are given one test drug or comparator once a day for 48 weeks according to the&#xD;
        results of random assignments, and their HBV antiviral inhibitory effect and safety are&#xD;
        evaluated at 24 and 48 weeks visits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV&#xD;
        antiviral (HBV DNA &lt;69 IU/mL) effects.&#xD;
  &#xD;
        At the time of screening, potential test subjects of this test are selected by&#xD;
        retrospectively collecting information on disease status and prognosis-related factors,&#xD;
        including ETV administration information, among those who voluntarily agreed to participate&#xD;
        in this clinical trial.&#xD;
  &#xD;
        HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before&#xD;
        administering clinical trial drugs to test subjects who finally qualify for&#xD;
        selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is&#xD;
        randomly assigned to each test institution.&#xD;
  &#xD;
        Subjects are given one test drug or comparator once a day for 48 weeks according to the&#xD;
        results of random assignments, and their HBV antiviral inhibitory effect and safety are&#xD;
        evaluated at 24 and 48 weeks visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 29, 2024</primary_completion_date>
    <phase>Phase 4</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>HBV viral suppression rate</measure>
      <time_frame>at 48 weeks post-baseline</time_frame>
      <description>HBV viral suppression rate</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">196</enrollment>
    <condition>Hepatitis B, Chronic</condition>
    <arm_group>
      <arm_group_label>Treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Chronic Hepatitis B patients who pretreated with Entecavir</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparator group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Chronic Hepatitis B patients who pretreated with Entecavir</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vemliver tablet</intervention_name>
      <description>Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)</description>
      <arm_group_label>Treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Entecavir Tablet</intervention_name>
      <description>Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Entecavir</description>
      <arm_group_label>Comparator group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Participants aged 19 years and older as of the date of written consent.&#xD;
  &#xD;
            2. Individuals with a positive HBsAg for at least 24 weeks prior to screening or a&#xD;
               history of chronic hepatitis B.&#xD;
  &#xD;
            3. Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg as monotherapy&#xD;
               for at least 24 weeks and have expressed the intention to switch to Barakros tablets&#xD;
               or Bemeliver tablets.&#xD;
  &#xD;
            4. Participants with good adherence to ETV 0.5 mg monotherapy confirmed through&#xD;
               questionnaire (≥80%).&#xD;
  &#xD;
            5. Participants who have demonstrated viral suppression efficacy (HBV DNA &lt;69 IU/mL) and&#xD;
               are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48&#xD;
               weeks.&#xD;
  &#xD;
            6. Individuals who voluntarily agree to participate in the clinical trial and have signed&#xD;
               the informed consent form.&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
               Medical history or surgical (treatment) history at the time of screening visit:&#xD;
  &#xD;
               ① Individuals diagnosed with substance abuse or alcohol addiction within the past year&#xD;
               of screening.&#xD;
  &#xD;
                 -  Confirmed diagnosis of malignant tumors, including liver cancer, within the past&#xD;
                    5 years.&#xD;
  &#xD;
                      -  Organ or bone marrow transplant recipients.&#xD;
  &#xD;
               Coexisting conditions at the time of screening visit:&#xD;
  &#xD;
               ① Non-selective clinical signs/symptoms in non-selective liver disease.&#xD;
  &#xD;
                 -  Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.&#xD;
  &#xD;
                      -  Kidney disease patients requiring hemodialysis or peritoneal dialysis. ④&#xD;
                         Other clinically significant cardiovascular, respiratory, neurological, or&#xD;
                         psychiatric conditions considered inappropriate for participation in the&#xD;
                         clinical trial according to the participant's judgment.&#xD;
  &#xD;
               Laboratory test results at the time of screening visit:&#xD;
  &#xD;
               ① Co-infection with HCV and HIV.&#xD;
  &#xD;
                 -  Hemoglobin &lt;8 g/dL.&#xD;
  &#xD;
                      -  Impaired renal function. ④ ALT &gt;3 × ULN.&#xD;
  &#xD;
               Anticipated use of the following drugs during the specified period:&#xD;
  &#xD;
               During the clinical trial period:&#xD;
  &#xD;
                 -  Immunosuppressants.&#xD;
  &#xD;
                      -  Systemic corticosteroids administered at a dose equal to or greater than a&#xD;
                         restricted dose for more than 2 weeks.&#xD;
  &#xD;
                           -  Drugs affecting renal excretion, drugs with renal or hepatic toxicity.&#xD;
                              ④ Anti-HBV drugs other than investigational medicinal products. ⑤&#xD;
                              Hepatotonics.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kim HeeJin</last_name>
      <phone>+8210-9911-1728</phone>
      <email>hjkim221@daewoong.co.kr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Seoul National University Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>yunjun kim</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Entecavir</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Not yet decided</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000657
  org study id: DWVMLV_P401
  nct id: NCT06000657
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV
        antiviral (HBV DNA <69 IU/mL) effects.
  
        Subjects are given one test drug or comparator once a day for 48 weeks according to the
        results of random assignments, and their HBV antiviral inhibitory effect and safety are
        evaluated at 24 and 48 weeks visits.
  Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV
        antiviral (HBV DNA <69 IU/mL) effects.
  
        At the time of screening, potential test subjects of this test are selected by
        retrospectively collecting information on disease status and prognosis-related factors,
        including ETV administration information, among those who voluntarily agreed to participate
        in this clinical trial.
  
        HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before
        administering clinical trial drugs to test subjects who finally qualify for
        selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is
        randomly assigned to each test institution.
  
        Subjects are given one test drug or comparator once a day for 48 weeks according to the
        results of random assignments, and their HBV antiviral inhibitory effect and safety are
        evaluated at 24 and 48 weeks visits.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: HBV viral suppression rate
  time frame: at 48 weeks post-baseline
  description: HBV viral suppression rate
  arm group label: Treatment group
  arm group type: Experimental
  description: Chronic Hepatitis B patients who pretreated with Entecavir
  arm group label: Comparator group
  arm group type: Active Comparator
  description: Chronic Hepatitis B patients who pretreated with Entecavir
  intervention type: Drug
  intervention name: Vemliver tablet
  description: Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
  arm group label: Treatment group
  intervention type: Drug
  intervention name: Entecavir Tablet
  description: Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Entecavir
  arm group label: Comparator group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kim HeeJin
  phone: +8210-9911-1728
  email: hjkim221@daewoong.co.kr
  facility: 
  status: Recruiting
  contact: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis B
  mesh term: Hepatitis B, Chronic
  mesh term: Hepatitis
  mesh term: Entecavir
  sharing ipd: Undecided
  ipd description: Not yet decided