<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/NCT02966964</url>
  </required_header>
  <id_info>
    <org_study_id>EURECA001</org_study_id>
    <nct_id>NCT02966964</nct_id>
  </id_info>
  <brief_title>A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV</brief_title>
  <official_title>An Exploratory, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With Hepatitis B Virus(HBV)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uijeongbu St. Mary Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Uijeongbu St. Mary Hospital</source>
  <brief_summary>
    <textblock>
      The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2&#xD;
      group or control group randomly.&#xD;
&#xD;
      All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day&#xD;
      for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo&#xD;
      of DWPUR001 twice a day for 48 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2015</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of normalization of ALT level (≤1× ULN)(%)</measure>
    <time_frame>At the 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of normalization of ALT level (≤1× ULN)(%)</measure>
    <time_frame>At the 2, 8, 12, 24, 36, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of fibrosis marker(ELF score) compared with the baseline</measure>
    <time_frame>At the 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline</measure>
    <time_frame>At the 12, 24, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)</measure>
    <time_frame>At the 24, 48 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of HBV DNA level compared with baseline (IU/mL)</measure>
    <time_frame>At the 12, 24, 36, 48 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Hepatitis; Virus, Chronic, Type B</condition>
  <arm_group>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 500mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 300mg bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 Placebo bid</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWPUR001</intervention_name>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 300mg bid</arm_group_label>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 500mg bid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Tenofovir 300mg qd + DWPUR001 Placebo bid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients at the age in between 19 and 69 years at the time of agreement&#xD;
&#xD;
          2. Patients who had HBsAg-positive at least within 24 weeks or had a diagnosis with&#xD;
             chronic hepatic disease by image test within 24 weeks from the time of screening.&#xD;
&#xD;
          3. Patients who had HBeAg-positive and HBV DNA level≥20,000 IU/mL, or HBeAg-negative and&#xD;
             HBV DNA level≥2,000 IU/mL&#xD;
&#xD;
          4. Patients never treated with Tenofovir&#xD;
&#xD;
          5. Patients whose ALT level is more than 2 times of UNL at the time of screening&#xD;
&#xD;
          6. Patients prothrombin time prolonged≤4sec at the time of screening&#xD;
&#xD;
          7. Patients Total bilirubin level≤3.0mg/dL at the time of screening&#xD;
&#xD;
          8. Patients albumin level≥3.0g/dL at the time of screening&#xD;
&#xD;
          9. Patients ELF score≥8.5 at the time of screening&#xD;
&#xD;
         10. Patients who agree with the clinical trial voluntarily and sign on the agreement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. HIV, HCV or HDV infedted patients&#xD;
&#xD;
          2. Patients who have abnormal liver function caused by other diseases (e.g.&#xD;
             hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic&#xD;
             steatohepatitis, alpha 1 antitrypsin deficiency)&#xD;
&#xD;
          3. Patients who had suffered from variceal haemorrhage or hepatic encephalopathy&#xD;
&#xD;
          4. Patients who need/had liver transplant&#xD;
&#xD;
          5. Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity&#xD;
             gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis&#xD;
&#xD;
          6. Patients who have enteritis and colitis like peptic ulcer or Crohn's disease&#xD;
&#xD;
          7. Patients who have significant kidney disease, cardiovascular disease, lung disease,&#xD;
             nervous disease, self-immune disease, bone disease (ex: osteomalacia, osteopenia,&#xD;
             chronic osteomyelitis, osteopsathyrosis, osteochondrosis, multiple fracture) or&#xD;
             malignant tumor.&#xD;
&#xD;
          8. Patients who have systemic infection&#xD;
&#xD;
          9. Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir&#xD;
&#xD;
         10. Patients who have the generic problem as galactose intolerance, Lapp lactase&#xD;
             deficiency or glucose-galactose malabsorption&#xD;
&#xD;
         11. Patients described as below at the time of screening&#xD;
&#xD;
               -  Hb&lt;8g/dL&#xD;
&#xD;
               -  eGFR&lt;60mL/min/1.73m2&#xD;
&#xD;
               -  AFP level&gt;200ng/mL or had a diagnosis with hepatocellular carcinoma based on the&#xD;
                  radiology result within 24 weeks&#xD;
&#xD;
         12. Patients who had immune- or cytokine-based antiviral agents treatment (ex. Interferon&#xD;
             α, Peginterferon α), or immunosuppression therapy (ex. Cyclosporine, Tacrolimus) in 24&#xD;
             weeks at the time of screening&#xD;
&#xD;
         13. Patients who have to use the contraindication of comedication drugs during clinical&#xD;
             trial or can't get the wash-out period&#xD;
&#xD;
         14. Women of child-bearing potential not using an effective birth control method&#xD;
&#xD;
         15. Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand&#xD;
             the purpose and process of this clinical trial&#xD;
&#xD;
         16. Patients who participated in other clinical trial in 30 days prior to the enrollment&#xD;
             in this study&#xD;
&#xD;
         17. Patients who were determined inappropriate by the investigator to participate in this&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chang Wook Kim, M.D., Ph.D.</last_name>
    <phone>+82-31-847-2719</phone>
    <email>cwkim@catholic.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Korea University Ansan Hospital</name>
      <address>
        <city>Ansan-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Bundang CHA medical center</name>
      <address>
        <city>Bundang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Incheon St. Mary Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ajou University Medical Center</name>
      <address>
        <city>Suwon-si</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uijeongbu St. Mary Hospital</name>
      <address>
        <city>Uijongbu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>September 21, 2017</last_update_submitted>
  <last_update_submitted_qc>September 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uijeongbu St. Mary Hospital</investigator_affiliation>
    <investigator_full_name>Chang Wook Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</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/NCT02966964
org study id: EURECA001
nct id: NCT02966964
lead sponsor: 
collaborator: 
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2
      group or control group randomly.

      All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day
      for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo
      of DWPUR001 twice a day for 48 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The proportion of normalization of ALT level (≤1× ULN)(%)
time frame: At the 4 weeks
measure: The proportion of normalization of ALT level (≤1× ULN)(%)
time frame: At the 2, 8, 12, 24, 36, 48 weeks
measure: The change of fibrosis marker(ELF score) compared with the baseline
time frame: At the 48 weeks
measure: The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline
time frame: At the 12, 24, 48 weeks
measure: The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α)
time frame: At the 24, 48 weeks
measure: The change of HBV DNA level compared with baseline (IU/mL)
time frame: At the 12, 24, 36, 48 weeks
arm group label: Tenofovir 300mg qd + DWPUR001 500mg bid
arm group type: Experimental
description: Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months
arm group label: Tenofovir 300mg qd + DWPUR001 300mg bid
arm group type: Experimental
description: Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months
arm group label: Tenofovir 300mg qd + DWPUR001 Placebo bid
arm group type: Placebo Comparator
description: Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months
intervention type: Drug
intervention name: DWPUR001
arm group label: Tenofovir 300mg qd + DWPUR001 300mg bid
arm group label: Tenofovir 300mg qd + DWPUR001 500mg bid
intervention type: Drug
intervention name: Placebo
arm group label: Tenofovir 300mg qd + DWPUR001 Placebo bid
criteria: 
gender: All
minimum age: 19 Years
maximum age: 69 Years
healthy volunteers: No
last name: Chang Wook Kim, M.D., Ph.D.
phone: +82-31-847-2719
email: cwkim@catholic.ac.kr
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Uijeongbu St. Mary Hospital
investigator full name: Chang Wook Kim
investigator title: Professor
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis