<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/NCT04475224</url>
  </required_header>
  <id_info>
    <org_study_id>KP-100-ND004</org_study_id>
    <nct_id>NCT04475224</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury</brief_title>
  <official_title>A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration 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>
    <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 non-randomized, multicenter, confirmatory study by intrathecal administration&#xD;
      of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection,&#xD;
      in subjects with acute spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>Phase 3</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>Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration</measure>
    <time_frame>24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time course of ASIA motor score (total/ upper extremity / lower upper extremity)</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time course of ASIA sensory score</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time course of AIS classification</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time course of modified Frankel classification</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time course of neurological level of injury</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration</measure>
    <time_frame>12 weeks and 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of adverse events</measure>
    <time_frame>up to 24weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Acute Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Open-label</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KP-100IT</intervention_name>
    <description>Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times</description>
    <arm_group_label>Open-label</arm_group_label>
    <other_name>Hepatocyte Growth Factor</other_name>
    <other_name>HGF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At the time of consent (whether oral or written consent), the patient's age is over 18&#xD;
             years old and under 89 years old&#xD;
&#xD;
          -  Patients who have suffered a cervical spinal cord injury within the past 78 hours&#xD;
             whose AIS classification was A at 66 - 78 hours after injury-Written informed consent&#xD;
             has been obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The injury site is C1-C2 or C2-C3&#xD;
&#xD;
          -  The patient cannot start rehabilitation necessary for recovery of function at an early&#xD;
             stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory&#xD;
             support is necessary&#xD;
&#xD;
          -  It is predicted that it will not be possible to administer the first dose of the study&#xD;
             drug within 78 hours after the cervical spinal cord injury&#xD;
&#xD;
          -  A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or&#xD;
             marked breakdown of the meninges other than SCI&#xD;
&#xD;
          -  Efficacy and safety cannot be evaluated properly due to such as concurrent multiple&#xD;
             external trauma or concurrent organ injury&#xD;
&#xD;
          -  High dose steroid therapy administered for spinal cord injury&#xD;
&#xD;
          -  Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia,&#xD;
             metabolic disease, or infections requiring systemic therapy&#xD;
&#xD;
          -  History of malignant tumor&#xD;
&#xD;
          -  Participation in a clinical study or research of pharmaceuticals or medical devices&#xD;
             within 1 month before registration&#xD;
&#xD;
          -  Drug allergies to drugs that will be (or may be) used&#xD;
&#xD;
          -  Administration of the study drug to the site of spinal cord injury is inappropriate&#xD;
             for a reason such as intrathecal infection or intrathecal mass&#xD;
&#xD;
          -  Problems with the subject's ability to give informed consent in person&#xD;
&#xD;
          -  The subject is breastfeeding or possibly pregnant&#xD;
&#xD;
          -  The subject cannot be expected to survive more than 180 days after the start of&#xD;
             administration of the study drug, in the judgement of the investigator&#xD;
&#xD;
          -  It is inappropriate for the subject to be included in the study, in the judgement of&#xD;
             the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 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>
  <overall_contact>
    <last_name>Etsuro Hashimura</last_name>
    <phone>+81-72-641-8739</phone>
    <email>hashimura@kringle-pharma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daichika Hayata</last_name>
    <phone>+81-72-641-8739</phone>
    <email>hayata@kringle-pharma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Spinal Injuries Center</name>
      <address>
        <city>Iizuka</city>
        <state>Fukuoka</state>
        <zip>820-8508</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Takeshi Maeda, MD, PhD</last_name>
      <phone>+81-948-24-7500</phone>
    </contact>
    <investigator>
      <last_name>Takeshi Maeda, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hokkaido Spinal Cord Injury Center</name>
      <address>
        <city>Bibai</city>
        <state>Hokkaido</state>
        <zip>072-0015</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kota Suda, MD, PhD</last_name>
      <phone>+81-126-63-2151</phone>
    </contact>
    <investigator>
      <last_name>Kota Suda, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Kobe Hospital</name>
      <address>
        <city>Kobe</city>
        <state>Hyogo</state>
        <zip>651-0073</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yasuo Ito, MD, PhD</last_name>
      <phone>+81-78-231-6006</phone>
    </contact>
    <investigator>
      <last_name>Yasuo Ito, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aijinkai Rehabilitation Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-1116</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mihoko Matsuoka, MD,PhD</last_name>
      <phone>+81-72-683-1212</phone>
    </contact>
    <investigator>
      <last_name>Mihoko Matsuoka, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Murayama Medical Center</name>
      <address>
        <city>Musashimurayama</city>
        <state>Tokyo</state>
        <zip>208-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tsunehiko Konomi, MD, PhD</last_name>
      <phone>+81-42-561-1221</phone>
    </contact>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</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>KP-100</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/NCT04475224
org study id: KP-100-ND004
nct id: NCT04475224
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is non-randomized, multicenter, confirmatory study by intrathecal administration
      of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection,
      in subjects with acute spinal cord injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
time frame: 24 weeks
measure: Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
time frame: up to 24weeks
measure: Time course of ASIA sensory score
time frame: up to 24weeks
measure: Time course of AIS classification
time frame: up to 24weeks
measure: Time course of modified Frankel classification
time frame: up to 24weeks
measure: Time course of neurological level of injury
time frame: up to 24weeks
measure: Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration
time frame: 12 weeks and 24 weeks
measure: Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
time frame: up to 24weeks
measure: Evaluation of adverse events
time frame: up to 24weeks
arm group label: Open-label
arm group type: Other
intervention type: Drug
intervention name: KP-100IT
description: Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
arm group label: Open-label
other name: Hepatocyte Growth Factor
other name: HGF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Etsuro Hashimura
role: Study Director
affiliation: Kringle Pharma, Inc.
last name: Etsuro Hashimura
phone: +81-72-641-8739
email: hashimura@kringle-pharma.com
last name: Daichika Hayata
phone: +81-72-641-8739
email: hayata@kringle-pharma.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Japan
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
mesh term: Mitogens