Recruiting
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder - CV185-118
Updated: 19 December, 2019 | ClinicalTrials.gov
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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 Exclusion Criteria: - 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])
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