Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT00487656
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation
Sponsor:
Organization:
Raw JSON
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'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'dispFirstSubmitDate': '2011-05-06', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-13', 'studyFirstSubmitDate': '2007-06-15', 'dispFirstSubmitQcDate': '2011-05-06', 'studyFirstSubmitQcDate': '2007-06-15', 'dispFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-Day All-cause mortality', 'timeFrame': '28 day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Sepsis', 'Disseminated Intravascular Coagulation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if ART-123 (recombinant human soluble thrombomodulin) decreases the number of people who die as a result of Disseminated Intravascular Coagulation (DIC) complication of sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infection or suspected infection resulting in sepsis and DIC\n\nExclusion Criteria:\n\n* Unable to provide informed consent, or lack of consent from an acceptable surrogate\n* Subjects \\< 18 years of age\n* Known conditions that could confound the diagnosis of DIC due to sepsis\n* Known conditions that increase the risk of bleeding\n* Known medical condition associated with a hypercoagulable state\n* Known or suspected severe liver disease\n* History of solid organ (excluding uncomplicated kidney), bone marrow or stem cell transplantation\n* Renal failure'}, 'identificationModule': {'nctId': 'NCT00487656', 'briefTitle': 'Safety and Efficacy of ART-123 in Subjects With Sepsis and Disseminated Intravascular Coagulation', 'nctIdAliases': ['NCT01090115'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Artisan Pharma, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Phase-2B Study to Assess the Safety and Efficacy Effects of ART-123 on Subjects With Sepsis and Disseminated Intravascular Coagulation', 'orgStudyIdInfo': {'id': '2-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ART-123', 'description': '6 mg/ml ampule solution for injection', 'interventionNames': ['Drug: ART-123']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 mg/mlampule of solution for injection', 'interventionNames': 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