Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-01 @ 12:37 PM
Study NCT ID:
NCT06696703
Status:
RECRUITING
Last Update Posted:
2024-11-20
First Post:
2024-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}, {'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2024-11-16', 'studyFirstSubmitQcDate': '2024-11-19', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Favorable Stroke Outcome of 90 days', 'timeFrame': '90 days after treatment', 'description': 'mRS 0-2'}, {'measure': 'The changes of the serum inflammatory markers before and after treatment', 'timeFrame': 'Baseline、1 day after treatment、3 days after treatment、90 days after treatment', 'description': 'Complete Blood Count、CRP、IL-6、HCY、NSE'}], 'secondaryOutcomes': [{'measure': 'The changes of NIHSS before and after treatment', 'timeFrame': 'Baseline、7 days after treatment', 'description': 'National Institute of Health stroke scale, NIHSS'}, {'measure': 'Stroke recurrence rate', 'timeFrame': '90 days after treatment', 'description': 'Ischemic stroke'}, {'measure': 'The incidence of intracranial hemorrhage', 'timeFrame': '90 days after treatment', 'description': 'Symptomatic intracranial hemorrhage'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute ischemic stroke', 'Urinary Kallidinogen', 'Inflammatory factors', '90 days functional outcomes'], 'conditions': ['Acute Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.', 'detailedDescription': 'The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;\n2. First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）\n3. Age≥18 years, male or female;\n4. 3≤Baseline NIHSS≤25;\n5. Written informed consent obtained from the patient or legally responsible person.\n\nExclusion Criteria:\n\n1. Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；\n2. Previously allergic or intolerant to injectable HUK；\n3. Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;\n4. Stent surgery after the AIS onset or planned interventional therapy;\n5. Pregnancy, lactation or planned pregnancy；\n6. Life expectancy of less than 3months or inability to complete the study for other reasons；\n7. Unwilling to be followed up or poor compliance；\n8. Current participation in other clinical research;\n9. Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).'}, 'identificationModule': {'nctId': 'NCT06696703', 'briefTitle': 'Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)', 'orgStudyIdInfo': {'id': '2023155'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Urinary Kallidinogenase for injection (HUK)', 'description': 'Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment', 'interventionNames': ['Drug: Human urinary kininogenase(HUK)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'sham-HUK treatment', 'description': 'Normal sodium chloride injection plus routine clinical treatment', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Human urinary kininogenase(HUK)', 'type': 'DRUG', 'otherNames': ['Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065'], 'description': 'Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day.', 'armGroupLabels': ['Human Urinary Kallidinogenase for injection (HUK)']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Normal sodium chloride injection'], 'description': 'Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day.', 'armGroupLabels': ['sham-HUK treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '150001', 'city': 'Harbin', 'state': 'Heilongjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongling Zhang', 'role': 'CONTACT', 'email': 'zhang777hyd@163.com', 'phone': '+8613503615988'}], 'facility': 'Zhongling Zhang', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}], 'centralContacts': [{'name': 'Zhongling Zhang', 'role': 'CONTACT', 'email': 'zhang777hyd@163.com', 'phone': '+8613503615988'}, {'name': 'shanshan yang', 'role': 'CONTACT', 'email': 'yangshanshan81@163.com', 'phone': '+8613845104003'}], 'overallOfficials': [{'name': 'Zhongling Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Harbin Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Zhongling Zhang', 'investigatorAffiliation': 'First Affiliated Hospital of Harbin Medical University'}}}}