<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/NCT02193334</url>
  </required_header>
  <id_info>
    <org_study_id>KP-100-ND002</org_study_id>
    <nct_id>NCT02193334</nct_id>
  </id_info>
  <brief_title>Phase I/II Study of KP-100IT in Acute Spinal Cord Injury</brief_title>
  <official_title>A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kringle Pharma, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kringle Pharma, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is randomized, double-blind, placebo-controlled Phase I/II study designed to&#xD;
      evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation&#xD;
      for intrathecal injection, as a treatment for acute spinal cord injury. The study is&#xD;
      conducted at two clinical sites in Japan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2014</start_date>
  <completion_date type="Actual">July 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2017</primary_completion_date>
  <phase>Phase 1/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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and degree of adverse events</measure>
    <time_frame>24 weeks</time_frame>
    <description>Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of ASIA motor score from baseline at 12 weeks</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-dependent change of ASIA motor score from baseline</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-dependent change of ASIA sensory score from baseline</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-dependent grade change of modified Frankel scale from baseline</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>KP-100IT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KP-100IT</intervention_name>
    <arm_group_label>KP-100IT</arm_group_label>
    <other_name>Hepatocyte Growth Factor</other_name>
    <other_name>HGF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age equal to or greater than 18 years and equal to or less than 75 years&#xD;
&#xD;
          -  Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72&#xD;
             hours since the injury&#xD;
&#xD;
          -  Subjects able to provide written informed concent, which may require a relative to&#xD;
             sign if arm/hand function of the subject is compromised&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Spinal cord injury at C1-C2 0r C2-C3 level&#xD;
&#xD;
          -  Patients not to able to start rehabilitation within a week by setup of respirator or&#xD;
             other reason&#xD;
&#xD;
          -  First dose of the study drug will not be given within 78 hours since the injury&#xD;
&#xD;
          -  History of spinal cord injury or abnormality in spinal cavity. Or current considerable&#xD;
             meningeal damage&#xD;
&#xD;
          -  Outcome assessment will not be conducted adequately through damage on injuries other&#xD;
             than the injury&#xD;
&#xD;
          -  High-dose steroid therapy within 30 days before the entry&#xD;
&#xD;
          -  Patients who have diseases such as serious liver disorder, renal disorder, hear&#xD;
             disease, blood dyscrasia, metabolism disorder and infections&#xD;
&#xD;
          -  History of malignant tumor&#xD;
&#xD;
          -  Patients who participated in other clinical study within 30 days before the entry&#xD;
&#xD;
          -  Patients who have allergies to drug scheduled to be used in the study&#xD;
&#xD;
          -  Administration of the study drug to the area of spinal cord injury is not appropriate&#xD;
             for example by intrathecal infections or intrathecal tumor&#xD;
&#xD;
          -  Patients not able to understand &quot;informed consent&quot; properly&#xD;
&#xD;
          -  Patients who are nursing or may be pregnant&#xD;
&#xD;
          -  Investigator considers that the patient is not appropriate for participating in the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Etsuro HASHIMURA</last_name>
    <role>Study Director</role>
    <affiliation>Kringle Pharma, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Spinal Injuries Center</name>
      <address>
        <city>Iizuka</city>
        <state>Fukuoka</state>
        <zip>820-8508</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Chuo Rosai Hospital Sekison Center</name>
      <address>
        <city>Bibai</city>
        <state>Hokkaido</state>
        <zip>072-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>June 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <last_update_submitted>June 3, 2019</last_update_submitted>
  <last_update_submitted_qc>June 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hepatocyte Growth Factor</keyword>
  <keyword>HGF</keyword>
  <keyword>KP-100IT</keyword>
  <keyword>Intrathecal injection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
  </intervention_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/NCT02193334
org study id: KP-100-ND002
nct id: NCT02193334
lead sponsor: 
has dmc: Yes
This study is randomized, double-blind, placebo-controlled Phase I/II study designed to
      evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation
      for intrathecal injection, as a treatment for acute spinal cord injury. The study is
      conducted at two clinical sites in Japan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number and degree of adverse events
time frame: 24 weeks
description: Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation
measure: Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
time frame: 24 weeks
measure: Change of ASIA motor score from baseline at 12 weeks
time frame: 12 weeks
measure: Time-dependent change of ASIA motor score from baseline
time frame: 24 weeks
measure: Time-dependent change of ASIA sensory score from baseline
time frame: 24 weeks
measure: Time-dependent grade change of modified Frankel scale from baseline
time frame: 24 weeks
measure: Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
time frame: 6 weeks
arm group label: KP-100IT
arm group type: Active Comparator
description: Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
arm group label: Placebo
arm group type: Placebo Comparator
description: Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times
intervention type: Drug
intervention name: KP-100IT
arm group label: KP-100IT
other name: Hepatocyte Growth Factor
other name: HGF
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Etsuro HASHIMURA
role: Study Director
affiliation: Kringle Pharma, Inc.
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Mitogens