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

A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Spinal Cord Injury
• Intervention / Treatment: Drug: KP-100IT

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Etsuro Hashimura; Phone Number: +81-72-641-8739; Email: hashimura@kringle-pharma.com
• Study Contact Backup: Name: Daichika Hayata; Phone Number: +81-72-641-8739; Email: hayata@kringle-pharma.com

Study Locations

• Japan
  • Fukuoka
    • Iizuka, Fukuoka, Japan, 820-8508
      • Recruiting
      • Spinal Injuries Center
      • Contact: Takeshi Maeda, MD, PhD; Phone Number: +81-948-24-7500
      • Principal Investigator: Takeshi Maeda, MD, PhD
  • Hokkaido
    • Bibai, Hokkaido, Japan, 072-0015
      • Recruiting
      • Hokkaido Spinal Cord Injury Center
      • Contact: Kota Suda, MD, PhD; Phone Number: +81-126-63-2151
      • Principal Investigator: Kota Suda, MD, PhD
  • Hyogo
    • Kobe, Hyogo, Japan, 651-0073
      • Recruiting
      • Japanese Red Cross Kobe Hospital
      • Contact: Yasuo Ito, MD, PhD; Phone Number: +81-78-231-6006
      • Principal Investigator: Yasuo Ito, MD, PhD
  • Osaka
    • Takatsuki, Osaka, Japan, 569-1116
      • Recruiting
      • Aijinkai Rehabilitation Hospital
      • Contact: Mihoko Matsuoka, MD,PhD; Phone Number: +81-72-683-1212
      • Principal Investigator: Mihoko Matsuoka, MD, PhD
  • Tokyo
    • Musashimurayama, Tokyo, Japan, 208-0011
      • Recruiting
      • Murayama Medical Center
      • Contact: Tsunehiko Konomi, MD, PhD; Phone Number: +81-42-561-1221

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Open-label	Drug: KP-100IT; Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times; Other Names: Hepatocyte Growth Factor; HGF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)	up to 24weeks
Time course of ASIA sensory score	up to 24weeks
Time course of AIS classification	up to 24weeks
Time course of modified Frankel classification	up to 24weeks
Time course of neurological level of injury	up to 24weeks
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	12 weeks and 24 weeks
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration	up to 24weeks
Evaluation of adverse events	up to 24weeks

Collaborators and Investigators

• Sponsor: Kringle Pharma, Inc.
• Investigators: Study Director: Etsuro HASHIMURA, Kringle Pharma, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: HGF; Hepatocyte Growth Factor; KP-100; KP-100IT; Intrathecal injection
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: KP-100-ND004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No