Phase I/II Study of KP-100IT in Acute Spinal Cord Injury

NCT ID: NCT02193334

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2018-07-31

Brief Summary

This study is randomized, double-blind, placebo-controlled Phase I/II study designed to evaluate safety and efficacy of KP-100IT, code of Hepatocyte Growth Factor (HGF) formulation for intrathecal injection, as a treatment for acute spinal cord injury. The study is conducted at two clinical sites in Japan.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

KP-100IT

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

Group Type: ACTIVE_COMPARATOR

KP-100IT

Intervention Type: DRUG

Placebo

Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

KP-100IT

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Hepatocyte Growth Factor; HGF

Eligibility Criteria

Inclusion Criteria

• Age equal to or greater than 18 years and equal to or less than 75 years
• Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury
• Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised

Exclusion Criteria

• Spinal cord injury at C1-C2 0r C2-C3 level
• Patients not to able to start rehabilitation within a week by setup of respirator or other reason
• First dose of the study drug will not be given within 78 hours since the injury
• History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage
• Outcome assessment will not be conducted adequately through damage on injuries other than the injury
• High-dose steroid therapy within 30 days before the entry
• Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections
• History of malignant tumor
• Patients who participated in other clinical study within 30 days before the entry
• Patients who have allergies to drug scheduled to be used in the study
• Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor
• Patients not able to understand "informed consent" properly
• Patients who are nursing or may be pregnant
• Investigator considers that the patient is not appropriate for participating in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kringle Pharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etsuro HASHIMURA

Role: STUDY_DIRECTOR

Kringle Pharma, Inc.

Locations

Spinal Injuries Center

Iizuka, Fukuoka, Japan

Hokkaido Chuo Rosai Hospital Sekison Center

Bibai, Hokkaido, Japan

Countries

Japan

Other Identifiers

KP-100-ND002

Identifier Type: -

Identifier Source: org_study_id