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Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

Primary Purpose

Acute Spinal Cord Injury

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
KP-100IT
Sponsored by
Kringle Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury focused on measuring Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
  • Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained

Exclusion Criteria:

  • The injury site is C1-C2 or C2-C3
  • The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary
  • It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury
  • A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI
  • Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury
  • High dose steroid therapy administered for spinal cord injury
  • Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy
  • History of malignant tumor
  • Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration
  • Drug allergies to drugs that will be (or may be) used
  • Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass
  • Problems with the subject's ability to give informed consent in person
  • The subject is breastfeeding or possibly pregnant
  • The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator
  • It is inappropriate for the subject to be included in the study, in the judgement of the investigator

Sites / Locations

  • Spinal Injuries CenterRecruiting
  • Hokkaido Spinal Cord Injury CenterRecruiting
  • Japanese Red Cross Kobe HospitalRecruiting
  • Aijinkai Rehabilitation HospitalRecruiting
  • Murayama Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open-label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Time course of ASIA sensory score
Time course of AIS classification
Time course of modified Frankel classification
Time course of neurological level of injury
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 courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
Evaluation of adverse events

Full Information

First Posted
July 12, 2020
Last Updated
August 25, 2022
Sponsor
Kringle Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04475224
Brief Title
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Official Title
A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kringle Pharma, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury
Keywords
Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
KP-100IT
Other Intervention Name(s)
Hepatocyte Growth Factor, HGF
Intervention Description
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Time Frame
up to 24weeks
Title
Time course of ASIA sensory score
Time Frame
up to 24weeks
Title
Time course of AIS classification
Time Frame
up to 24weeks
Title
Time course of modified Frankel classification
Time Frame
up to 24weeks
Title
Time course of neurological level of injury
Time Frame
up to 24weeks
Title
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
Title
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
Time Frame
up to 24weeks
Title
Evaluation of adverse events
Time Frame
up to 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old Patients who have suffered a cervical spinal cord injury within the past 78 hours whose AIS classification was A at 66 - 78 hours after injury-Written informed consent has been obtained Exclusion Criteria: The injury site is C1-C2 or C2-C3 The patient cannot start rehabilitation necessary for recovery of function at an early stage, for example because tracheal intubation, tracheotomy, or mechanical ventilatory support is necessary It is predicted that it will not be possible to administer the first dose of the study drug within 78 hours after the cervical spinal cord injury A history of SCI (Spinal cord injury), or abnormal findings in the spinal cavity or marked breakdown of the meninges other than SCI Efficacy and safety cannot be evaluated properly due to such as concurrent multiple external trauma or concurrent organ injury High dose steroid therapy administered for spinal cord injury Disease such as serious liver disorder, renal disease, heart disease, blood dyscrasia, metabolic disease, or infections requiring systemic therapy History of malignant tumor Participation in a clinical study or research of pharmaceuticals or medical devices within 1 month before registration Drug allergies to drugs that will be (or may be) used Administration of the study drug to the site of spinal cord injury is inappropriate for a reason such as intrathecal infection or intrathecal mass Problems with the subject's ability to give informed consent in person The subject is breastfeeding or possibly pregnant The subject cannot be expected to survive more than 180 days after the start of administration of the study drug, in the judgement of the investigator It is inappropriate for the subject to be included in the study, in the judgement of the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Etsuro Hashimura
Phone
+81-72-641-8739
Email
hashimura@kringle-pharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Daichika Hayata
Phone
+81-72-641-8739
Email
hayata@kringle-pharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etsuro Hashimura
Organizational Affiliation
Kringle Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Spinal Injuries Center
City
Iizuka
State/Province
Fukuoka
ZIP/Postal Code
820-8508
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Maeda, MD, PhD
Phone
+81-948-24-7500
First Name & Middle Initial & Last Name & Degree
Takeshi Maeda, MD, PhD
Facility Name
Hokkaido Spinal Cord Injury Center
City
Bibai
State/Province
Hokkaido
ZIP/Postal Code
072-0015
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kota Suda, MD, PhD
Phone
+81-126-63-2151
First Name & Middle Initial & Last Name & Degree
Kota Suda, MD, PhD
Facility Name
Japanese Red Cross Kobe Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
651-0073
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasuo Ito, MD, PhD
Phone
+81-78-231-6006
First Name & Middle Initial & Last Name & Degree
Yasuo Ito, MD, PhD
Facility Name
Aijinkai Rehabilitation Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-1116
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihoko Matsuoka, MD,PhD
Phone
+81-72-683-1212
First Name & Middle Initial & Last Name & Degree
Mihoko Matsuoka, MD, PhD
Facility Name
Murayama Medical Center
City
Musashimurayama
State/Province
Tokyo
ZIP/Postal Code
208-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsunehiko Konomi, MD, PhD
Phone
+81-42-561-1221

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury

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