Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
NCT ID: NCT04475224
Last Updated: 2022-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
25 participants
INTERVENTIONAL
2020-07-13
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open-label
KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Interventions
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KP-100IT
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
89 Years
ALL
No
Sponsors
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Kringle Pharma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Etsuro Hashimura
Role: STUDY_DIRECTOR
Kringle Pharma, Inc.
Locations
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Spinal Injuries Center
Iizuka, Fukuoka, Japan
Hokkaido Spinal Cord Injury Center
Bibai, Hokkaido, Japan
Japanese Red Cross Kobe Hospital
Kobe, Hyōgo, Japan
Aijinkai Rehabilitation Hospital
Takatsuki, Osaka, Japan
Murayama Medical Center
Musashimurayama, Tokyo, Japan
Countries
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Central Contacts
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Facility Contacts
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Takeshi Maeda, MD, PhD
Role: primary
Kota Suda, MD, PhD
Role: primary
Yasuo Ito, MD, PhD
Role: primary
Mihoko Matsuoka, MD,PhD
Role: primary
Tsunehiko Konomi, MD, PhD
Role: primary
Other Identifiers
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KP-100-ND004
Identifier Type: -
Identifier Source: org_study_id
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