Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 1:42 PM
Study NCT ID:
NCT03853369
Status:
UNKNOWN
Last Update Posted:
2019-03-14
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D014693', 'term': 'Ventricular Fibrillation'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C076259', 'term': 'nifekalant'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-12', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.', 'timeFrame': 'From the beginning of the administration to 48 hours after the end of the administration.', 'description': 'The efficiency during the treatment and observation periods, including the rate of termination / prevention of ventricular tachycardia / ventricular fibrillation attack and relapse.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with adverse events', 'timeFrame': 'From the beginning of the administration to 48 hours after the end of the administration.', 'description': 'Number of Participants with Tdp, ventricular tachycardia or ventricular fibrillation.'}, {'measure': 'Heart rate', 'timeFrame': '3 days before the beginning of the administration to 48 hours after the end of the administration.', 'description': "The subjects' heart rate will be recorded and the abnormalities will be analyzed."}, {'measure': 'The survival rate', 'timeFrame': '30 days after the end of administration.', 'description': 'The 30 days survival rate.'}, {'measure': 'Blood pressure', 'timeFrame': '3 days before the beginning of the administration to 48 hours after the end of the administration.', 'description': 'Both systolic and diastolic pressures will be assessed during the study period.'}, {'measure': 'Respiratory rate', 'timeFrame': '3 days before the beginning of the administration to 48 hours after the end of the administration.', 'description': 'The respiratory status of all subjects will be recorded the incidence of abnormalities will be calculated.'}, {'measure': 'Body temperature', 'timeFrame': '3 days before the beginning of the administration to 48 hours after the end of the administration.', 'description': "The subjects' temperatures will be recorded and the abnormalities will be analyzed."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ventricular tachycardia', 'ventricular fibrillation'], 'conditions': ['Ventricular Tachycardia', 'Ventricular Fibrillation']}, 'descriptionModule': {'briefSummary': 'Retrospective and Prospective single arm, observational study to evaluate efficacy and safety of NIF in the treatment of ventricular tachycardia and ventricular fibrillation. The information registration of the target population will be collected with the hospital HIS system or LIS system.', 'detailedDescription': "Subjects enrolled in the retrospective study may be enrolled in a prospective study if the study drug is re-used, but in the end only the most-registered case of the subject would be collected.\n\nThe recommended treatment plan for this study is from the usage and dosage of NIF. The clinician can make appropriate adjustments to the specific usage and dosage according to the patient's condition.\n\nLoad dose: Adults usually use 0.3mg/kg each time, under continuous ECG monitoring, the injection should be completed within 5 minutes, and the maximum dose should not exceed 0.5 mg/kg.\n\nMaintenance dose: After load injection, the adult routine dose is 0.4 mg/kg/h under continuous ECG monitoring. The dosage could be appropriately increased or decreased according to the patient's reaction, but the maximum dose should not exceed 0.8 mg/kg/h."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with life-threatening ventricular tachycardia or ventricular fibrillation in cases where other drugs are ineffective or inoperable.\n* Patients who have received or are about to receive Nifekalant Hydrochloride for treatment according to the instructions.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03853369', 'briefTitle': 'Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sichuan Baili Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Post-marketing Registration Study of Nifekalant Hydrochloride (NIF) Injection', 'orgStudyIdInfo': {'id': 'NPMR01/ GUSU18002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Nifekalant hydrochloride', 'type': 'DRUG', 'otherNames': ['Nifekalant Hydrochloride for Injection'], 'description': 'Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Zhou', 'role': 'CONTACT', 'phone': '+86-136 5118 5517'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jing Xiong', 'role': 'CONTACT', 'email': 'xiongjing@baili-pharm.com', 'phone': '+86-028-85320612'}], 'overallOfficials': [{'name': 'Yong Huo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}, {'name': 'Jing Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}, {'name': 'Min Yi Cui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}, {'name': 'Xin Hu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Baili Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}