<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/NCT02967939</url>
  </required_header>
  <id_info>
    <org_study_id>DA2802_HB_III</org_study_id>
    <nct_id>NCT02967939</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients</brief_title>
  <official_title>Phase III Clinical Trial to Evaluate the Antiviral Activity and Safety of DA-2802(Tenofovir Disoproxil Orotate) and Viread®(Tenofovir Disoproxil Fumarate) in Chronic Hepatitis B Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A ST Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic&#xD;
      hepatitis B patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet&#xD;
           matching to Viread® 300mg for 0-48 weeks.&#xD;
&#xD;
        2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet&#xD;
           matching to DA-2802 319mg for 0-48 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Actual">July 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 23, 2019</primary_completion_date>
  <phase>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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of HBV DNA level(log10)</measure>
    <time_frame>Change from baseline at 48 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects HBV DNA &lt; 400 copies/ml</measure>
    <time_frame>at 24 weeks, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who had normal ALT levels</measure>
    <time_frame>at 24 week, 48 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects who experienced loss of HBeAg</measure>
    <time_frame>at 24 week, 48 week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Hepatitis B， Chronic</condition>
  <arm_group>
    <arm_group_label>DA-2802</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DA-2802 319mg tablet qd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Viread®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Viread® 300mg tablet qd</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DA-2802</intervention_name>
    <description>DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.</description>
    <arm_group_label>DA-2802</arm_group_label>
    <other_name>tenofovir disoproxil orotate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Viread®</intervention_name>
    <description>Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.</description>
    <arm_group_label>Viread®</arm_group_label>
    <other_name>tenofovir disoproxil fumarate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with chronic hepatitis B aged 18 years or older&#xD;
&#xD;
          -  Subjects who have evidence to demonstrate a history of chronic hepatitis B for at&#xD;
             least six months from the time of screening visit&#xD;
&#xD;
          -  Subjects who have HBsAg positive test at screening visit&#xD;
&#xD;
          -  Subjects who did not receive the hepatitis B treatment, including interferon or&#xD;
             pegylated interferon, within 24 weeks of starting the screening test&#xD;
&#xD;
          -  Subjects with an ALT of 80 units or more and 10 times lower than the normal upper&#xD;
             limit at the time of screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus&#xD;
&#xD;
          -  Subjects with creatinine clearance of less than 50 ml/min at the screening visit&#xD;
&#xD;
          -  At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and&#xD;
             related imaging test showed hepatocellular carcinoma&#xD;
&#xD;
          -  Subjects with decompensated liver disease who meet the following criteria:&#xD;
&#xD;
               1. Total bilirubin levels greater than 2.5 mg/dl&#xD;
&#xD;
               2. Prothrombin time is at least 3 seconds longer than normal upper limit&#xD;
&#xD;
               3. Serum albumin value less than 30 g/l&#xD;
&#xD;
               4. Subjects with a history of ascites, jaundice, bleeding from varicose veins,&#xD;
                  hepatic encephalopathy, or other signs of liver failure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jong eun Yeon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 13, 2021</last_update_submitted>
  <last_update_submitted_qc>April 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2021</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>Tenofovir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02967939
org study id: DA2802_HB_III
nct id: NCT02967939
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic
      hepatitis B patients
1. DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet
           matching to Viread® 300mg for 0-48 weeks.

        2. Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet
           matching to DA-2802 319mg for 0-48 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference of HBV DNA level(log10)
time frame: Change from baseline at 48 weeks
measure: Percentage of subjects HBV DNA < 400 copies/ml
time frame: at 24 weeks, 48 weeks
measure: Percentage of subjects who had normal ALT levels
time frame: at 24 week, 48 week
measure: Percentage of subjects who experienced loss of HBeAg
time frame: at 24 week, 48 week
arm group label: DA-2802
arm group type: Experimental
description: DA-2802 319mg tablet qd
arm group label: Viread®
arm group type: Active Comparator
description: Viread® 300mg tablet qd
intervention type: Drug
intervention name: DA-2802
description: DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
arm group label: DA-2802
other name: tenofovir disoproxil orotate
intervention type: Drug
intervention name: Viread®
description: Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
arm group label: Viread®
other name: tenofovir disoproxil fumarate
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jong eun Yeon
role: Principal Investigator
affiliation: Korea University Guro Hospital
facility: 
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: Tenofovir
sharing ipd: No