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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Spinal Cord Injury

Intervention / Treatment
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* Drug: KP-100IT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open-label<br> | Drug: KP-100IT<br>* Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times<br>* Other names: HGF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection