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

NCT02193334 | Completed Phase 1 DMC

• 1 other identifier: KP-100-ND002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number and degree of adverse events

  Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation

  24 weeks

• Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks

  24 weeks

Secondary Outcomes (5)

• Change of ASIA motor score from baseline at 12 weeks

  12 weeks

• Time-dependent change of ASIA motor score from baseline

  24 weeks

• Time-dependent change of ASIA sensory score from baseline

  24 weeks

• Time-dependent grade change of modified Frankel scale from baseline

  24 weeks

• Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid

  6 weeks

Study Arms (2)

KP-100IT

ACTIVE COMPARATOR

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

Drug: KP-100IT

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

KP-100IT DRUG

Also known as: Hepatocyte Growth Factor, HGF

KP-100IT

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kringle Pharma, Inc.: lead

Study Sites (2)

Spinal Injuries Center

Iizuka, Fukuoka, 820-8508, Japan

Location

Hokkaido Chuo Rosai Hospital Sekison Center

Bibai, Hokkaido, 072-0015, Japan

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Deafness, Autosomal Recessive 39

Interventions

Hepatocyte Growth Factor

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 17, 2014
• Study Start: June 30, 2014
• Primary Completion: December 21, 2017
• Study Completion: July 31, 2018
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

JP (2)