UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014434 |
|---|---|
| Receipt number | R000016795 |
| Scientific Title | Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury |
| Date of disclosure of the study information | 2014/06/30 |
| Last modified on | 2018/12/03 09:33:15 |
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Basic information
Public title
Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury
Acronym
Phase I/II study of KP-100IT in acute spinal cord injury
Scientific Title
Phase I/II study to evaluate the safety and efficacy of intrathecal injection of KP-100IT in subjects with acute spinal cord injury
Scientific Title:Acronym
Phase I/II study of KP-100IT in acute spinal cord injury
Region
| Japan |
Condition
Condition
Spinal Cord Injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse events
Change of ASIA motor score from baseline at 24 weeks
Key secondary outcomes
ASIA sensory score
Grade change of modified Frankel scale
Concentration of KP-100 in plasma and cerebrospinal fluid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intrathecal injection of KP-100IT
Interventions/Control_2
Intrathecal injection of placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Spinal cord injury at cervical level
-Grade A, B1 or B2 in the modified Frankel scale at 72 hours since the injury.
-Patients able to provide written informed consent, which may require a reltative to sign if arm/hand function is compromised.
Key exclusion criteria
-Spinal cord injury at C1-C2 or C2-C3 level
-Patients not 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, abnormality in spinal cavity, or considerable meningeal damage
-Evaluation of safety and efficacy will not be conducted adequately by damage on brain, organs or multiple injuries
-High-dose steroid therapy within 30 days before the entry
-Patients who have diseases such as serious liver disorder, renal disorder, heart 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 drugs scheduled to be used in the study
-Administration of the study drug to the area of spinal cord injury is not appropriate because of 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
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro, Hashimura |
Organization
Kringle Pharma, Inc.
Division name
Department of Pharmaceutical Development
Zip code
Address
Saito Biotechnology Incubator, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL
072-641-8739
hashimura@kringle-pharma.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daichika, Hayata |
Organization
Kringle Pharma, Inc.
Division name
Department of Pharmaceutical Development
Zip code
Address
Saito Biotechnology Incubator, 7-7-15 Saito-Asagi, Ibaraki, Osaka 567-0085 Japan
TEL
072-641-8739
Homepage URL
hayata@kringle-pharma.com
Sponsor or person
Institute
Kringle Pharma, Inc.
Institute
Department
Personal name
Funding Source
Organization
Japan Agent for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio University School of Medicine
Name of secondary funder(s)
Kringle Pharma, Inc.
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
総合せき損センター(福岡県)、
北海道せき損センター(北海道)、
村山医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016795
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
