Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-29 @ 3:14 PM
Study NCT ID:
NCT01384903
Status:
COMPLETED
Last Update Posted:
2017-03-24
First Post:
2011-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study of KW-3357
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004211', 'term': 'Disseminated Intravascular Coagulation'}], 'ancestors': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 221}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2011-06-27', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DIC resolution', 'timeFrame': '6 days (or discontinuation)', 'description': 'Japanese Association for Acute Medicine-defined DIC criteria score \\< 4'}], 'secondaryOutcomes': [{'measure': 'DIC score', 'timeFrame': 'Screening, 2, 3, 4, 5, 6 days (or discontinuation)', 'description': 'Based on the Japanese Association for Acute Medicine-defined DIC criteria score'}, {'measure': 'Mortality', 'timeFrame': '28 days'}, {'measure': 'Organ symptoms', 'timeFrame': 'Screening, 4, 6 days (or discontinuation)', 'description': 'Sepsis related organ failure assessment score'}, {'measure': 'Severity', 'timeFrame': 'Screening, 4, 6 days (or discontinuation)', 'description': 'The Acute Physiology and Chronic Health Evaluation II score'}, {'measure': 'Plasma antithrombin activity', 'timeFrame': 'Screening, 2, 3, 4, 5, 6 days (or discontinuation)'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 6 days (or discontinuation)'}]}, 'conditionsModule': {'conditions': ['Disseminated Intravascular Coagulation (DIC)']}, 'referencesModule': {'references': [{'pmid': '30473794', 'type': 'DERIVED', 'citation': 'Endo S, Shimazaki R; Antithrombin Gamma Study Group. An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome. J Intensive Care. 2018 Nov 16;6:75. doi: 10.1186/s40560-018-0339-z. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the ACCP/SCCM-defined sepsis criteria\n* Japanese Association for Acute Medicine-defined DIC criteria score \\>= 4\n* Antithrombin activity \\<= 70%\n* Written informed consent from patient or guardian\n\nExclusion Criteria:\n\n* Anamnesis or complication of serious drug allergy\n* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis\n* Pregnant, nursing, or possibly pregnant woman'}, 'identificationModule': {'nctId': 'NCT01384903', 'acronym': '3357-004', 'briefTitle': 'An Open-label Study of KW-3357', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection', 'orgStudyIdInfo': {'id': '3357-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KW-3357', 'interventionNames': ['Drug: KW-3357']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plasma-derived antithrombin', 'interventionNames': ['Drug: Plasma-derived antithrombin']}], 'interventions': [{'name': 'KW-3357', 'type': 'DRUG', 'description': 'Intravenous infusion once a day', 'armGroupLabels': ['KW-3357']}, {'name': 'Plasma-derived antithrombin', 'type': 'DRUG', 'description': 'Intravenous infusion once a day', 'armGroupLabels': ['Plasma-derived antithrombin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}