Clinical trial NCT04475224: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Spinal Cord Injury
Keywords: Hepatocyte Growth Factor
HGF
KP-100IT
KP-100
Intrathecal injection
Lead sponsor: Kringle Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: 24 weeks
Secondary outcomes:
measure: Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
timeFrame: up to 24weeks
measure: Time course of ASIA sensory score
timeFrame: up to 24weeks
measure: Time course of AIS classification
timeFrame: up to 24weeks
measure: Time course of modified Frankel classification
timeFrame: up to 24weeks
measure: Time course of neurological level of injury
timeFrame: 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
timeFrame: 12 weeks and 24 weeks
measure: Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
timeFrame: up to 24weeks
measure: Evaluation of adverse events
timeFrame: up to 24weeks
Other outcomes:
Locations:
city: Iizuka
country: Japan
facility: Spinal Injuries Center
state: Fukuoka
city: Bibai
country: Japan
facility: Hokkaido Spinal Cord Injury Center
state: Hokkaido
city: Kobe
country: Japan
facility: Japanese Red Cross Kobe Hospital
state: Hyogo
city: Takatsuki
country: Japan
facility: Aijinkai Rehabilitation Hospital
state: Osaka
city: Musashimurayama
country: Japan
facility: Murayama Medical Center
state: Tokyo
Study officials:
affiliation: Kringle Pharma, Inc.
name: Etsuro Hashimura
role: STUDY_DIRECTOR
References: