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

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

Full Study Title: Study to Evaluate a Single Dose of Apixaban in Pediatric Subjects at Risk for a Thrombotic Disorder

Summary

CV185118 is a single dose Apixaban PK/PD study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects at risk for thrombosis

Participant Eligibility

Inclusion Criteria:

  • Subjects with stable disease that are at risk for a venous or arterial thrombotic Neonates > 37 weeks gestation at birth to < 18 years of age

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

Study ID: NCT01707394

Study Sites
Children’s Hospital of Wisconsin/Medical College of Wisconsin

Principal Investigator(s)
Bristol-Myers Squibb

Contact
Sheila Hanson M.D.
414-266-3360
shanson@mcw.edu