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

Updated: 24 June, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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


  • Gender(s)

  • 0-18

    Age Range

  • 6


  • Recruiting

Treatment Options

Study Arms
Experimental: Group 1: Apixaban (low dose)
Drug: Apixaban
Experimental: Group 2A (higher dose): Apixaban (low dose)
Drug: Apixaban
Experimental: Group 2A: 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: - 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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Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information