Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-02 @ 3:23 AM
Study NCT ID:
NCT03270735
Status:
UNKNOWN
Last Update Posted:
2017-09-01
First Post:
2017-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006469', 'term': 'Hemoptysis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-31', 'studyFirstSubmitDate': '2017-06-09', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs and SAEs', 'timeFrame': '7 days', 'description': 'The incidence of AEs and SAEs'}], 'secondaryOutcomes': [{'measure': 'Effective rate of treating hemoptysis', 'timeFrame': '72 hours', 'description': 'Effective rate of treating hemoptysis 72 hours after administration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemoptysis']}, 'descriptionModule': {'briefSummary': 'This is a multi-centre, randomised, double blind, placebo controlled clinical study which is designed to evaluate the efficacy and safety of hemocoagulase in the treatment of moderate to severe hemoptysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-75 years;\n* Hemoptysis \\>=100 mL within 24 hours;\n* Bronchiectasis diagnosed by chest high resolution CT;\n* Patient, family or guardian is willing to sign the informed consent form.\n\nExclusion Criteria:\n\n* With severe hepatic or renal insufficiency, ALT\\>3 ULN, creatinine clearance \\<30 mL/min or serum creatinine ≥200 µmol/L or ≥2.5 mg/dL;\n* Uncontrollable hypertension (SBP\\>180mmHg or DBP\\>110mmHg) or hypotension shock (SBP\\<90 mmHg) at randomization;\n* History of thrombosis, patients who have undergone thrombosis, or who have severe hematologic diseases;\n* Patient with bleeding caused by DIC or vascular disease;\n* Patient with coagulation dysfunction\n\n 1. INR\\>2\n 2. Patient with abnormal coagulation function or other bleeding disease (including clinical congenital bleeding disorders, such as von Willebrand disease or acquired hemophilia; hemorrhagic disease; and significant unexplained hemorrhagic disease)\n 3. Platelet count \\<100×109 /L;\n* known allergic to aspirin, clopidogrel, heparin, snake venom blood clotting enzyme, or any component in the study drug allergy or allergic constitution;\n* Women who are pregnant or lactating and women of child-bearing agewho do not take reliable contraceptive measures;\n* Patients who are or are planning to participate in other clinical trials during the study period;\n* Within 72 hours before using the following products including Hemocoagulase For Injection (邦亭®), injection spearhead haemocoagulase (巴曲亭®), Haemocoagulase Agkistrodon for Injection (苏灵®), Hemocoagulase Atrox for Injection (立止血®), leaf pigment or other hemostatic agents;\n* Life expectancy of less than 3 months;\n* Any other patients who have been judged unfit to participate in this clinical study, including those who are unable or unwilling to comply with the protocol requirements;\n* Patients who had participated in other clinical studies within three months prior to the study.'}, 'identificationModule': {'nctId': 'NCT03270735', 'briefTitle': 'A Clinical Study to Evaluate the Efficacy and Safety of Hemocoagulase Injection', 'organization': {'class': 'INDUSTRY', 'fullName': "Lee's Pharmaceutical Limited"}, 'officialTitle': 'A Multi-centre, Randomised, Double Blind, Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Snake Venom Thrombin Injection in the Treatment of Moderate to Severe Hemoptysis', 'orgStudyIdInfo': {'id': '2016-ZK-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Snake venom thrombin', 'interventionNames': ['Drug: Snake venom thrombin (Treatment)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Snake venom thrombin simulant', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Snake venom thrombin (Treatment)', 'type': 'DRUG', 'otherNames': ['Snake venom thrombin'], 'description': 'Snake venom thrombin', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Snake venom thrombin simulant'], 'description': 'No snake venom thrombin', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuhui Zhang, MD', 'role': 'CONTACT', 'email': 'yuhuizhangjoy@163.com', 'phone': '86-10-88322674'}], 'facility': 'Fuwai Hospital Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Nan Yang, MD, PhD', 'role': 'CONTACT', 'email': 'nancy.yang@leespharm.com', 'phone': '852-23146533'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Lee's Pharmaceutical Limited", 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zhaoke Pharmaceutical (Hefei) Company Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}