Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
NCT ID: NCT01707394
Last Updated: 2021-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2013-01-10
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 2A: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 2B: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 3: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 4: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 5: Apixaban (low dose)
Apixaban
Specified dose on specified days
Group 2A (higher dose): Apixaban (low dose)
Apixaban
Specified dose on specified days
Interventions
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Apixaban
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to \<18 years of age
* Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
* Neonates: defined as newly born (within 4 weeks)
* Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system
Exclusion Criteria
* Active bleeding or high risk of bleeding
* Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube \[NG tube\] or gastronomy tube \[G-tube\])
1 Day
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Children'S Hospital Of Orange County
Orange, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare Of Atlanta
Atlanta, Georgia, United States
Blank Childrens Hospital
Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, United States
Saint Peter'S University Hospital
New Brunswick, New Jersey, United States
Duke University Medical Center
Durham, North Carolina, United States
ProMedica Toledo Children's Hospital
Toledo, Ohio, United States
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hopsital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, United States
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, United States
Childrens Hospital Of Wisconsin
Milwaukee, Wisconsin, United States
Local Institution
Parkville, Victoria, Australia
University of Alberta - Edmonton Clinic Health Academy
Edmonton, Alberta, Canada
Local Institution
Hamilton, Ontario, Canada
The Hospital For Sick Children
Toronto, Ontario, Canada
Local Institution
Ramat Gan, , Israel
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Monterrey, Nuevo León, Mexico
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2012-001581-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV185-118
Identifier Type: -
Identifier Source: org_study_id
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