Spinal Cord InjuriesPhase 1/2NCT02193334
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
A Phase 1/2 study testing KP-100IT in people with Spinal Cord Injuries, run by Kringle Pharma, Inc. at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- KP-100IT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesJapan
- Study dates
- 30 Jun 2014to 31 Jul 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido, 072-0015
Spinal Injuries Center
Iizuka, Fukuoka, 820-8508
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
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
- Being tested
- KP-100IT, Placebo
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100IT, Intrathecal injection
- Medical subject headings
- Spinal Cord Injuries, Deafness, Autosomal Recessive 39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KP-100ITDrug
Also called Hepatocyte Growth Factor, HGF
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KP-100IT | Active comparator | Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times Receives: Drug: KP-100IT |
| Placebo | Placebo comparator | Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Measured: 24 weeks
Secondary outcomes (5)
Change of ASIA motor score from baseline at 12 weeks
Measured: 12 weeks
Time-dependent change of ASIA motor score from baseline
Measured: 24 weeks
Time-dependent change of ASIA sensory score from baseline
Measured: 24 weeks
Time-dependent grade change of modified Frankel scale from baseline
Measured: 24 weeks
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start30 Jun 2014
- Primary completion21 Dec 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kringle Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etsuro HASHIMURA, Study director, Kringle Pharma, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193334
- Sponsor's protocol ID
- KP-100-ND002
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2014
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02193334
- Acronym / sponsor ID
- KP-100-ND002
- Conditions
- Spinal Cord Injuries
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100IT, Intrathecal injection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kringle Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2014 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KP-100IT | Active comparator | Drug: KP-100ITIntrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times |
| Placebo | Placebo comparator | Drug: PlaceboIntrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KP-100ITAlso: Hepatocyte Growth Factor, HGF | Drug | KP-100IT |
| Placebo | Drug | Placebo |
Primary outcome
Number and degree of adverse events
Time frame: 24 weeks
Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation
Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks
Time frame: 24 weeks
5 secondary outcomes
Change of ASIA motor score from baseline at 12 weeks
Time frame: 12 weeks
Time-dependent change of ASIA motor score from baseline
Time frame: 24 weeks
Time-dependent change of ASIA sensory score from baseline
Time frame: 24 weeks
Time-dependent grade change of modified Frankel scale from baseline
Time frame: 24 weeks
Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etsuro HASHIMURA study director
Kringle Pharma, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KP-100IT in people with Spinal Cord Injuries, run by Kringle Pharma, Inc. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and degree of adverse events (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.