Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT01195727
Status:
TERMINATED
Last Update Posted:
2017-04-07
First Post:
2010-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-06', 'studyFirstSubmitDate': '2010-09-03', 'studyFirstSubmitQcDate': '2010-09-03', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data', 'timeFrame': 'Days 1, 2, Day 5, 6 or 7 and Day 11'}], 'secondaryOutcomes': [{'measure': 'Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis', 'timeFrame': 'Days 1, 2, Day 5, 6 or 7'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}, {'url': 'http://www.bms.com/studyconnect/pages/home.aspx', 'label': 'BMS Clinical Trial Education Resource'}]}, 'descriptionModule': {'briefSummary': 'CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.\n* \\> 12 to \\<18 years of age\n\nExclusion Criteria:\n\n* Current or recent (within 3 months of study drug administration) gastrointestinal disease or gastrointestinal surgery that, in the opinion of the investigator and the BMS Medical Monitor, could impact the absorption of the study drug\n* Active bleeding or high risk of bleeding'}, 'identificationModule': {'nctId': 'NCT01195727', 'briefTitle': 'Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter', 'orgStudyIdInfo': {'id': 'CV185-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 5A - Apixaban (Low Dose)', 'description': 'Group 5: 12 years to \\<18 years;\n\n0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5B - Apixaban (High Dose)', 'description': 'Group 5: 12 years to \\<18 years;\n\n1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['BMS-562247'], 'armGroupLabels': ['Group 5A - Apixaban (Low Dose)', 'Group 5B - Apixaban (High Dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children'S Hospital Of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter'S University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "The Toledo Children'S Hospital", 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Penn State Hershey Children'S Hospital", 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Local Institution', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '04530', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '11000', 'city': 'Mexico, D. F.', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '72190', 'city': 'Puebla City', 'state': 'Puebla', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Local Institution', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}