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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014434
Receipt No. 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

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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
Email 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
Email hayata@kringle-pharma.com

Sponsor
Institute Kringle Pharma, Inc.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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