Acute Spinal Cord InjuryPhase 3NCT04475224
Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury
A Phase 3 study testing KP-100IT in people with Acute Spinal Cord Injury, run by Kringle Pharma, Inc. at 5 sites in Japan.
Trial summary
This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- KP-100IT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 5 sitesJapan
- Study dates
- 13 Jul 2020to 30 Jun 2023
- Phase
- Phase 3
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
- 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
Who cannot join
- The injury site is C1-C2 or C2-C3
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites, 5 recruiting
- Recruiting
Hokkaido Spinal Cord Injury Center
Bibai, Hokkaido, 072-0015
Kota Suda, MD, PhD, +81-126-63-2151
Kota Suda, MD, PhD
- Recruiting
Spinal Injuries Center
Iizuka, Fukuoka, 820-8508
Takeshi Maeda, MD, PhD, +81-948-24-7500
Takeshi Maeda, MD, PhD
- Recruiting
Japanese Red Cross Kobe Hospital
Kobe, Hyōgo, 651-0073
Yasuo Ito, MD, PhD, +81-78-231-6006
Yasuo Ito, MD, PhD
- Recruiting
Murayama Medical Center
Musashimurayama, Tokyo, 208-0011
Tsunehiko Konomi, MD, PhD, +81-42-561-1221
- Recruiting
Aijinkai Rehabilitation Hospital
Takatsuki, Osaka, 569-1116
Mihoko Matsuoka, MD,PhD, +81-72-683-1212
Mihoko Matsuoka, MD, PhD
About this study
Official title: A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
This study is non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- KP-100IT
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection
- Medical subject headings
- 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
Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Other | Not described Receives: Drug: KP-100IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
Measured: 24 weeks
Secondary outcomes (8)
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Measured: up to 24weeks
Time course of ASIA sensory score
Measured: up to 24weeks
Time course of AIS classification
Measured: up to 24weeks
Time course of modified Frankel classification
Measured: up to 24weeks
Time course of neurological level of injury
Measured: up to 24weeks
Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration
Measured: 12 weeks and 24 weeks
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
Measured: up to 24weeks
Evaluation of adverse events
Measured: up to 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start13 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
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
- NCT04475224
- Sponsor's protocol ID
- KP-100-ND004
- Status last verified
- Aug 2022
- First submitted
- 12 Jul 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Multicenter, Confirmatory Study by Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04475224
- Acronym / sponsor ID
- KP-100-ND004
- Conditions
- Acute Spinal Cord Injury
- Keywords
- Hepatocyte Growth Factor, HGF, KP-100IT, KP-100, Intrathecal injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kringle Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 17 Jul 2020 (actual)
- 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 non-randomized, multicenter, confirmatory study by intrathecal administration of KP-100IT, code of HGF (Hepatocyte Growth Factor ) formulation for intrathecal injection, in subjects with acute spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Other | Drug: KP-100IT |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At the time of consent (whether oral or written consent), the patient's age is over 18 years old and under 89 years old
- 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
Key exclusion criteria (15 listed)
- The injury site is C1-C2 or C2-C3
- 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
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, HGFIntrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times | Drug | Open-label |
Primary outcome
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration
Time frame: 24 weeks
8 secondary outcomes
Time course of ASIA motor score (total/ upper extremity / lower upper extremity)
Time frame: up to 24weeks
Time course of ASIA sensory score
Time frame: up to 24weeks
Time course of AIS classification
Time frame: up to 24weeks
Time course of modified Frankel classification
Time frame: up to 24weeks
Time course of neurological level of injury
Time frame: up to 24weeks
Percentage of subjects improving by at least 10 points on the ASIA motor score at 12 weeks and 24 weeks after administration relative to before study drug administration
Time frame: 12 weeks and 24 weeks
Time courses of plasma concentration and cerebrospinal fluid concentration of KP-100IT after intrathecal administration
Time frame: up to 24weeks
Evaluation of adverse events
Time frame: up to 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KP-100IT in people with Acute Spinal Cord Injury, run by Kringle Pharma, Inc. at 5 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Etsuro Hashimura (+81-72-641-8739, hashimura@kringle-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects with an improvement of at least two AIS (American Spinal Injury Association) grade, A to C/D, at 24 weeks after administration (time frame: 24 weeks). 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 26 Aug 2022.