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

NCT04475224 | Unknown Phase 3 DMC

• 1 other identifier: KP-100-ND004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Spinal Cord Injury

Keywords

Hepatocyte Growth Factor; HGF; KP-100IT; KP-100; Intrathecal injection

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• 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

Study Arms (1)

Open-label

OTHER

Drug: KP-100IT

Interventions

KP-100IT DRUG

Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times

Also known as: Hepatocyte Growth Factor, HGF

Open-label

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kringle Pharma, Inc.: lead

Study Sites (5)

Spinal Injuries Center

Iizuka, Fukuoka, 820-8508, Japan

RECRUITING

Hokkaido Spinal Cord Injury Center

Bibai, Hokkaido, 072-0015, Japan

RECRUITING

Japanese Red Cross Kobe Hospital

Kobe, Hyōgo, 651-0073, Japan

RECRUITING

Aijinkai Rehabilitation Hospital

Takatsuki, Osaka, 569-1116, Japan

RECRUITING

Murayama Medical Center

Musashimurayama, Tokyo, 208-0011, Japan

RECRUITING

MeSH Terms

Conditions

Deafness, Autosomal Recessive 39

Interventions

Hepatocyte Growth Factor

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Etsuro Hashimura

  Kringle Pharma, Inc.

  STUDY DIRECTOR

Central Study Contacts

Etsuro Hashimura

CONTACT

+81-72-641-8739; hashimura@kringle-pharma.com

Daichika Hayata

CONTACT

+81-72-641-8739; hayata@kringle-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 17, 2020
• Study Start: July 13, 2020
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: August 26, 2022

Record last verified: 2022-08

Locations

JP (5)