<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/NCT01704001</url>
  </required_header>
  <id_info>
    <org_study_id>ART-123 IV-2</org_study_id>
    <nct_id>NCT01704001</nct_id>
  </id_info>
  <brief_title>Clinical Pharmacokinetics Study of ART-123 in Disseminated Intravascular Coagulation (DIC) Subjects With Renal Impairment</brief_title>
  <official_title>A Post-Marketing Clinical Pharmacokinetics Study of ART-123 in DIC Subjects With Renal Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asahi Kasei Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asahi Kasei Pharma Corporation</source>
  <brief_summary>
    <textblock>
      To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in&#xD;
      patients with Disseminated Intravascular Coagulation.&#xD;
&#xD;
      To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite of Pharmacokinetics</measure>
    <time_frame>pre-dose, 0,2,4,8,24 hours post-dose</time_frame>
    <description>Cmax, Area Under Curve, T1/2,CLtot,CLR</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of hemorrhage related adverse events</measure>
    <time_frame>from the start of infusion to 8days after the cessation of infusion</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Disseminated Intravascular Coagulation</condition>
  <arm_group>
    <arm_group_label>Renal impairment grade 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Renal impairment grade 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Renal impairment grade 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Renal impairment grade 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ART-123</intervention_name>
    <description>380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days</description>
    <arm_group_label>Renal impairment grade 0</arm_group_label>
    <arm_group_label>Renal impairment grade 1</arm_group_label>
    <arm_group_label>Renal impairment grade 2</arm_group_label>
    <arm_group_label>Renal impairment grade 3</arm_group_label>
    <other_name>Recomodulin™</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Japanese Association for Acute Medicine-defined DIC criteria score &gt;= 4&#xD;
&#xD;
          -  Written informed consent from patient or guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients showing intracranial, pulmonary, gastrointestinal hemorrhage&#xD;
&#xD;
          -  Patients with a history of cerebrovascular disorders within the past 52 week&#xD;
&#xD;
          -  Patients with a history of hypersensitivity to the ingredients of ART-123 preparations&#xD;
&#xD;
          -  Pregnant women, nursing mothers or possibly pregnant women&#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>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>February 13, 2017</last_update_submitted>
  <last_update_submitted_qc>February 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ART-123</keyword>
  <keyword>Disseminated Intravascular Coagulation</keyword>
  <keyword>Pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disseminated Intravascular Coagulation</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/NCT01704001
org study id: ART-123 IV-2
nct id: NCT01704001
lead sponsor: 
To investigate the impact of impaired renal function on the pharmacokinetics of ART-123 in
      patients with Disseminated Intravascular Coagulation.

      To investigate the safety of ART-123 in patients with Disseminated Intravascular Coagulation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Composite of Pharmacokinetics
time frame: pre-dose, 0,2,4,8,24 hours post-dose
description: Cmax, Area Under Curve, T1/2,CLtot,CLR
measure: Incidence rate of hemorrhage related adverse events
time frame: from the start of infusion to 8days after the cessation of infusion
arm group label: Renal impairment grade 0
arm group type: Experimental
arm group label: Renal impairment grade 1
arm group type: Experimental
arm group label: Renal impairment grade 2
arm group type: Experimental
arm group label: Renal impairment grade 3
arm group type: Experimental
intervention type: Drug
intervention name: ART-123
description: 380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
arm group label: Renal impairment grade 0
arm group label: Renal impairment grade 1
arm group label: Renal impairment grade 2
arm group label: Renal impairment grade 3
other name: Recomodulin™
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Disseminated Intravascular Coagulation