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

Acute Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04475224
• Other study ID #: KP-100-ND004
• Status: Recruiting
• Phase: Phase 3
• Start date: July 13, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: Kringle Pharma, Inc.
• Contact: Etsuro Hashimura
• Phone: +81-72-641-8739
• Email: hashimura[@]kringle-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Drug:
• KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times

Locations

Country	Name	City	State
Japan	Hokkaido Spinal Cord Injury Center	Bibai	Hokkaido
Japan	Spinal Injuries Center	Iizuka	Fukuoka
Japan	Japanese Red Cross Kobe Hospital	Kobe	Hyogo
Japan	Murayama Medical Center	Musashimurayama	Tokyo
Japan	Aijinkai Rehabilitation Hospital	Takatsuki	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Kringle Pharma, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

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