Status:
UNKNOWN
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
Lead Sponsor:
Kringle Pharma, Inc.
Conditions:
Acute Spinal Cord Injury
Eligibility:
All Genders
18-89 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04475224
Start Date
July 13 2020
End Date
June 30 2023
Last Update
August 26 2022
Active Locations (5)
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1
Spinal Injuries Center
Iizuka, Fukuoka, Japan, 820-8508
2
Hokkaido Spinal Cord Injury Center
Bibai, Hokkaido, Japan, 072-0015
3
Japanese Red Cross Kobe Hospital
Kobe, Hyōgo, Japan, 651-0073
4
Aijinkai Rehabilitation Hospital
Takatsuki, Osaka, Japan, 569-1116