<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/NCT02250391</url>
  </required_header>
  <id_info>
    <org_study_id>NPB-06-04/C-01</org_study_id>
    <nct_id>NCT02250391</nct_id>
  </id_info>
  <brief_title>Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis</brief_title>
  <official_title>Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nihon Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with portal vein thrombosis, who have chronic liver diseases especially liver&#xD;
      cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06&#xD;
      or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in&#xD;
      a randomized, double-blind, parallel-assignment design based on the proportion of patients&#xD;
      obtained complete recanalization or partial recanalization of portal vein thrombosis.&#xD;
&#xD;
      The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions&#xD;
      (ADRs) observed between administration and 21 days after administration in comparison with&#xD;
      the placebo group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis</measure>
    <time_frame>an expected average of 2 weeks</time_frame>
    <description>Contrast enhanced CT assessed by an independent radiologist</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients obtained complete recanalization of portal vein thrombosis</measure>
    <time_frame>an expected average of 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reduction rate of portal vein thrombosis</measure>
    <time_frame>Up to 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of Child-Pugh score</measure>
    <time_frame>Up to 5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in laboratory values (congealing fibrinogenolysis system)</measure>
    <time_frame>Up to 5 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration</measure>
    <time_frame>Up to 5 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Portal Vein Thrombosis</condition>
  <arm_group>
    <arm_group_label>NPB-06</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1,500 unit, 5 days continuous-infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>0 unit, 5 days continuous-infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPB-06</intervention_name>
    <description>5 days continuous-infusion</description>
    <arm_group_label>NPB-06</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>5 days continuous-infusion</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study.&#xD;
        Patients have to provide written informed consent for voluntary participation in the study.&#xD;
&#xD;
          1. Patients who the serum level of AT-III is 70% or less&#xD;
&#xD;
          2. Patients with portal vein thrombosis detected by ultrasonography&#xD;
&#xD;
          3. Patients who have more than 50% of the thrombus lumen occupancy&#xD;
&#xD;
          4. Patients who are older than 20 years at the time of consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of the following criteria will be excluded from the study beforehand.&#xD;
&#xD;
          1. Patients with tumor embolus in portal vein&#xD;
&#xD;
          2. Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable&#xD;
             reservoir system&#xD;
&#xD;
          3. Patients with hepatocellular cancer of more than 3 cm in diameter or more than four&#xD;
             hepatocellular cancers&#xD;
&#xD;
          4. Patients with residual or chronic portal vein thrombosis&#xD;
&#xD;
          5. Patients with advanced liver disease (Child-Pugh score 11 or more)&#xD;
&#xD;
          6. Patients with bleeding tendency&#xD;
&#xD;
          7. Patients who had an anticoagulation therapy (intravenous or subcutaneous dose) or&#xD;
             hemostasis with an enzymatic hemostatic agent in the period between 7 days before&#xD;
             contrast enhanced CT of pre-dose and the day acquired written informed consent&#xD;
&#xD;
          8. Patients who had an anticoagulation therapy (oral dose) in the period between 7 days&#xD;
             before contrast enhanced CT of pre-dose and the day acquired written informed consent&#xD;
&#xD;
          9. Patients with a history of shock or hypersensitivity to NPB-06&#xD;
&#xD;
         10. Patients with inappropriate to contrast agents&#xD;
&#xD;
               -  A history of allergy of iodine or X-ray contrast agent&#xD;
&#xD;
               -  Complication of serious thyroid disease&#xD;
&#xD;
               -  Reduced renal function&#xD;
&#xD;
         11. Pregnant or lactating women, women of childbearing potential, or women who plan to&#xD;
             become pregnant during the study&#xD;
&#xD;
         12. Patients who have received NPB-06&#xD;
&#xD;
         13. Patients who have received other investigational drugs within four months before&#xD;
             consent or who are participating in other clinical studies&#xD;
&#xD;
         14. Patients otherwise ineligible for participation in the study in the investigator's or&#xD;
             subinvestigator's opinion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Chubu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kanto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyushu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 20, 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>September 7, 2016</last_update_submitted>
  <last_update_submitted_qc>September 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2016</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>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</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/NCT02250391
org study id: NPB-06-04/C-01
nct id: NCT02250391
lead sponsor: 
has dmc: No
Patients with portal vein thrombosis, who have chronic liver diseases especially liver
      cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06
      or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in
      a randomized, double-blind, parallel-assignment design based on the proportion of patients
      obtained complete recanalization or partial recanalization of portal vein thrombosis.

      The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions
      (ADRs) observed between administration and 21 days after administration in comparison with
      the placebo group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis
time frame: an expected average of 2 weeks
description: Contrast enhanced CT assessed by an independent radiologist
measure: The proportion of patients obtained complete recanalization of portal vein thrombosis
time frame: an expected average of 2 weeks
measure: Reduction rate of portal vein thrombosis
time frame: Up to 3 weeks
measure: Improvement of Child-Pugh score
time frame: Up to 5 weeks
measure: Changes in laboratory values (congealing fibrinogenolysis system)
time frame: Up to 5 weeks
measure: Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration
time frame: Up to 5 weeks
arm group label: NPB-06
arm group type: Experimental
description: 1,500 unit, 5 days continuous-infusion
arm group label: Placebo
arm group type: Placebo Comparator
description: 0 unit, 5 days continuous-infusion
intervention type: Drug
intervention name: NPB-06
description: 5 days continuous-infusion
arm group label: NPB-06
intervention type: Drug
intervention name: Placebo
description: 5 days continuous-infusion
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Venous Thrombosis