<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/NCT03232177</url>
  </required_header>
  <id_info>
    <org_study_id>YMC018</org_study_id>
    <nct_id>NCT03232177</nct_id>
  </id_info>
  <brief_title>Anagre Cap. in Patients With High-Risk Essential Thrombocythemia</brief_title>
  <official_title>A Multicenter, Open-label, Clinical Study for Efficacy and Safety Evaluation of Anagrelide in Patients With Treatment-naïve, High-risk Essential Thrombocythemia as a Primary Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuhan Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuhan Corporation</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>
      This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks&#xD;
      and duration of administration for 1 year in patients with high-risk essential&#xD;
      thrombocythemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 5, 2017</start_date>
  <completion_date type="Actual">December 5, 2020</completion_date>
  <primary_completion_date type="Actual">December 5, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rate for less than 60 X 10^4/ul in platelet count</measure>
    <time_frame>at week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate for less than 60 X 10^4/ul in platelet count</measure>
    <time_frame>at week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes from baseline in 50% reduction rate in platelet count</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate for less than 40 X 10^4/ul in platelet count</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)</measure>
    <time_frame>at 52 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of adverse events</measure>
    <time_frame>up to 52 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>expression of MPN-oncogene(JAK2/CALR/MPL)</measure>
    <time_frame>at 52 week</time_frame>
    <description>association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations</description>
  </other_outcome>
  <other_outcome>
    <measure>genomic biomarker search for prediction of side effects of anagrelide</measure>
    <time_frame>at 52 week</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Essential Thrombocythemia</condition>
  <arm_group>
    <arm_group_label>Anagre Cap.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anagre Cap.</intervention_name>
    <description>from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks</description>
    <arm_group_label>Anagre Cap.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with essential thrombocythemia according to WHO 2008&#xD;
&#xD;
          -  Any of the following as high-risk patient&#xD;
&#xD;
               -  Over 60 years old&#xD;
&#xD;
               -  &gt;100 X 10^4/ul of platelet count&#xD;
&#xD;
               -  increased more than 300K of platelet count in 3 months&#xD;
&#xD;
               -  Hypertension, diabetes, past history of thromboembolic bleeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with an adverse drug reaction or intolerability to anagrelide&#xD;
&#xD;
          -  Any of the following cardiac abnormalities;&#xD;
&#xD;
               -  Complete left bundle branch block on ECG&#xD;
&#xD;
               -  Patients using a pacemaker&#xD;
&#xD;
               -  Patients with a family history of congenital QT prolongation syndrome or known QT&#xD;
                  prolongation syndrome&#xD;
&#xD;
               -  Currently, there is no clinically uncontrolled ventricular or atrial tachycardia&#xD;
&#xD;
               -  Clinically significant bradycardia (&lt;less than 50 per minute)&#xD;
&#xD;
               -  History of clinically proven myocardial infarction and unstable angina within 3&#xD;
                  months&#xD;
&#xD;
          -  Pregnant women, nursing mothers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Health Insurance Service Ilsan Hospital</name>
      <address>
        <city>Goyang</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea. ST. Vincents Hospital</name>
      <address>
        <city>Suwon-si</city>
        <state>Gyeonggi</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym UNIV. Medical Center</name>
      <address>
        <city>Anyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook national university hospital</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongguk University Medical Center</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cheonnam National University Hwasun Hospital</name>
      <address>
        <city>Hwasun</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeju National University Hospital</name>
      <address>
        <city>Jeju City</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Wonans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym UNIV. Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Sanggye Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SMG - SNU Boramae Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soon Chun Hyang University Hospital Seoul</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Health Service medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Health System, SEVERANCE HOSPITAL</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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>Thrombocytosis</mesh_term>
    <mesh_term>Thrombocythemia, Essential</mesh_term>
  </condition_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/NCT03232177
org study id: YMC018
nct id: NCT03232177
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the efficacy and safety according to incremental dosing for 8 weeks
      and duration of administration for 1 year in patients with high-risk essential
      thrombocythemia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate for less than 60 X 10^4/ul in platelet count
time frame: at week 8
measure: response rate for less than 60 X 10^4/ul in platelet count
time frame: at week 52
measure: changes from baseline in 50% reduction rate in platelet count
time frame: up to 52 weeks
measure: response rate for less than 40 X 10^4/ul in platelet count
time frame: up to 52 weeks
measure: cumulative incidence of essential thrombocythemia related events (e.g thromboembolic or hemorrhagic events)
time frame: at 52 week
measure: incidence of adverse events
time frame: up to 52 weeks
measure: expression of MPN-oncogene(JAK2/CALR/MPL)
time frame: at 52 week
description: association of known MPN-oncogene(JAK2/CALR/MPL) with epigenetic modifiers, mRNA splicing, oncogene and other minor somatic mutations
measure: genomic biomarker search for prediction of side effects of anagrelide
time frame: at 52 week
arm group label: Anagre Cap.
arm group type: Experimental
description: twice a day
intervention type: Drug
intervention name: Anagre Cap.
description: from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
arm group label: Anagre Cap.
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Thrombocytosis
mesh term: Thrombocythemia, Essential
sharing ipd: No