Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Completed · Phase 1

Conditions studied: Thromboembolism

In brief

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

Key facts

Study ID

NCT01707394

Run by

Bristol-Myers Squibb

People needed

49

Starts

2013-01-10

Expected to finish

2020-06-30

Last updated by the study team

2021-03-22

Who can join

Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder
• 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

You may not qualify if…

• 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
• 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])

Where it is running

• 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

Full record on ClinicalTrials.gov

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