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Recruiting

Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder - CV185-118

Updated: 06 August, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 16

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Group 1: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 2A: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 2AA: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 2B: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 3: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 4: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 5: Apixaban (low dose)
Drug: Apixaban

Key Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Subjects with any stable disease that are at risk for a venous or arterial thrombotic disorder - Neonates up to 28 days of age (>= 34 weeks gestational age or >= 37 weeks post conceptual age) to <18 years of age - Subjects 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])

Have questions? Email Us

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Email Us