Phase 3 Study of KP-100IT in Subjects With Acute Spinal C... | NCT04475224

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

NCT04475224

Sponsor

Kringle Pharma, Inc.

Status

Unknown status

Last Update Posted

Aug 26, 2022Actual

Enrollment

25Estimated

Phase

Phase 3

Conditions

Acute Spinal Cord Injury

Interventions

KP-100IT

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Jun 30, 2023Estimated

First Submitted Date

Jul 12, 2020

First Submission Date that Met QC Criteria

Jul 14, 2020

First Posted Date

Jul 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2022

Last Update Posted Date

Aug 26, 2022Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Label	Type	Description	Intervention Names
Open-label	Other		Drug: KP-100IT

Name	Type	Description	Arm Group Labels	Other Names
KP-100IT	Drug	Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times	Open-label

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Etsuro Hashimura	Contact	+81-72-641-8739		hashimura@kringle-pharma.com
Daichika Hayata	Contact	+81-72-641-8739		hayata@kringle-pharma.com

ID	Term
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins