Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-04-09 @ 5:52 PM
Study NCT ID:
NCT01707394
Status:
COMPLETED
Last Update Posted:
2021-03-22
First Post:
2012-10-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'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': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2012-10-12', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban', 'timeFrame': 'Up to 26 hours, post dose (from Day 1 to Day 2)'}, {'measure': 'Maximum estimated plasma concentration (Cmax) of Apixaban', 'timeFrame': 'Up to 26 hours, post dose (from Day 1 to Day 2)'}, {'measure': 'Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban', 'timeFrame': 'Up to 26 hours, post dose (from Day 1 to Day 2)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Number of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Vital Signs of body temperature', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Vital Signs of respiratory rate', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Vital Signs of blood pressure', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Vital Signs of heart rate', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Number of participants with abnormalities in Physical Examinations', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Clinical Laboratory Tests of blood', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Clinical Laboratory Tests of blood serum', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in International Normalized Ratio (INR) clotting activity during treatment', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Prothrombin Time (PT) clotting activity during treatment', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Change from baseline in Clinical Laboratory Tests of urine', 'timeFrame': 'Up to 30 Days after last dosing', 'description': 'Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing'}, {'measure': 'Pharmacodynamics will be analyzed using anti-Factor Xa activity', 'timeFrame': 'Up to 26 hours, post dose (from Day 1 to Day 2)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '36861188', 'type': 'DERIVED', 'citation': 'Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder\n* Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \\<18 years of age\n\n * Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age\n * Neonates: defined as newly born (within 4 weeks)\n* Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system\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\n* Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \\[NG tube\\] or gastronomy tube \\[G-tube\\])'}, 'identificationModule': {'nctId': 'NCT01707394', 'briefTitle': 'Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder', 'orgStudyIdInfo': {'id': 'CV185-118'}, 'secondaryIdInfos': [{'id': '2012-001581-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2A: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2B: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2A (higher dose): Apixaban (low dose)', 'interventionNames': ['Drug: Apixaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['BMS-562247'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group 1: Apixaban (low dose)', 'Group 2A (higher dose): Apixaban (low dose)', 'Group 2A: Apixaban (low dose)', 'Group 2B: Apixaban (low dose)', 'Group 3: Apixaban (low dose)', 'Group 4: Apixaban (low dose)', 'Group 5: Apixaban (low dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202-3591', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children'S Hospital", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children'S Hospital Of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare Of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Blank Childrens Hospital', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kosair Charities Pediatric Clinical Research Unit', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children'S Mercy Hospital And Clinics", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'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': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': "ProMedica 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': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Childrens Hospital Of Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hopsital Of Pittsburgh Of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15224', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital Of Pittsburgh Of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Childrens Hospital Of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Local Institution', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': 'T6G 1C9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta - Edmonton Clinic Health Academy', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'L8S 4K1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital For Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Local Institution', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '44260', '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': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Local Institution', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], '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'}}}}