Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-28 @ 9:32 AM
Study NCT ID:
NCT02193334
Status:
COMPLETED
Last Update Posted:
2019-06-05
First Post:
2014-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Study of KP-100IT in Acute Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'C564265', 'term': 'Deafness, Autosomal Recessive 39'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017228', 'term': 'Hepatocyte Growth Factor'}], 'ancestors': [{'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2014-06-27', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and degree of adverse events', 'timeFrame': '24 weeks', 'description': 'Adverse events will be judged by general condition, vital sign, electrocardiogram, MRI, blood chemistry, hematology, urinalysis, cerebrospinal fluid examination, and antibody formation'}, {'measure': 'Change of ASIA (American Spinal Injury Association) motor score from baseline at 24 weeks', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change of ASIA motor score from baseline at 12 weeks', 'timeFrame': '12 weeks'}, {'measure': 'Time-dependent change of ASIA motor score from baseline', 'timeFrame': '24 weeks'}, {'measure': 'Time-dependent change of ASIA sensory score from baseline', 'timeFrame': '24 weeks'}, {'measure': 'Time-dependent grade change of modified Frankel scale from baseline', 'timeFrame': '24 weeks'}, {'measure': 'Time-dependent change of P-100 concentration in plasma and cerebrospinal fluid', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatocyte Growth Factor', 'HGF', 'KP-100IT', 'Intrathecal injection'], 'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 years and equal to or less than 75 years\n* Cervical spinal cord injury, and Grade A, B1 or B2 in the modified Frankel Scale at 72 hours since the injury\n* Subjects able to provide written informed concent, which may require a relative to sign if arm/hand function of the subject is compromised\n\nExclusion Criteria:\n\n* Spinal cord injury at C1-C2 0r C2-C3 level\n* Patients not to able to start rehabilitation within a week by setup of respirator or other reason\n* First dose of the study drug will not be given within 78 hours since the injury\n* History of spinal cord injury or abnormality in spinal cavity. Or current considerable meningeal damage\n* Outcome assessment will not be conducted adequately through damage on injuries other than the injury\n* High-dose steroid therapy within 30 days before the entry\n* Patients who have diseases such as serious liver disorder, renal disorder, hear disease, blood dyscrasia, metabolism disorder and infections\n* History of malignant tumor\n* Patients who participated in other clinical study within 30 days before the entry\n* Patients who have allergies to drug scheduled to be used in the study\n* Administration of the study drug to the area of spinal cord injury is not appropriate for example by intrathecal infections or intrathecal tumor\n* Patients not able to understand "informed consent" properly\n* Patients who are nursing or may be pregnant\n* Investigator considers that the patient is not appropriate for participating in the study'}, 'identificationModule': {'nctId': 'NCT02193334', 'briefTitle': 'Phase I/II Study of KP-100IT in Acute Spinal Cord Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kringle Pharma, Inc.'}, 'officialTitle': 'A Phase I/II Study to Evaluate the Safety and Efficacy of Intrathecal Injection of KP-100IT in Subjects With Acute Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'KP-100-ND002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KP-100IT', 'description': 'Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times', 'interventionNames': ['Drug: KP-100IT']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Intrathecal injection of placebo starting at 72 hours since the injury and repeating weekly 5 times', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'KP-100IT', 'type': 'DRUG', 'otherNames': ['Hepatocyte Growth Factor', 'HGF'], 'armGroupLabels': ['KP-100IT']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '820-8508', 'city': 'Iizuka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Spinal Injuries Center', 'geoPoint': {'lat': 33.63654, 'lon': 130.68678}}, {'zip': '072-0015', 'city': 'Bibai', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Hokkaido Chuo Rosai Hospital Sekison Center', 'geoPoint': {'lat': 43.32472, 'lon': 141.85861}}], 'overallOfficials': [{'name': 'Etsuro HASHIMURA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kringle Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kringle Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}