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

Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder

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

Study Overview

• Status: Completed
• Conditions: Thromboembolism
• Intervention / Treatment: Drug: Apixaban

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Local Institution
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C9
      • University of Alberta - Edmonton Clinic Health Academy
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Local Institution
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children
• Israel
  • Ramat Gan, Israel, 52621
    • Local Institution
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 04530
      • Local Institution
    • Mexico City, Distrito Federal, Mexico, 14080
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44260
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Local Institution
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202-3591
      • Arkansas Children's Hospital
  • California
    • Orange, California, United States, 92868
      • Children's Hospital of Orange County
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
    • Washington, District of Columbia, United States, 20010
      • Childrens National Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • Blank Childrens Hospital
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Charities Pediatric Clinical Research Unit
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital and Clinics
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Saint Peter's University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Children's Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Children's Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Childrens Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh of UPMC
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hopsital of Pittsburgh of UPMC
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Childrens Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 2A: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 2B: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 3: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 4: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 5: Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247
Experimental: Group 2A (higher dose): Apixaban (low dose)	Drug: Apixaban; Specified dose on specified days; Other Names: BMS-562247

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban	Up to 26 hours, post dose (from Day 1 to Day 2)
Maximum estimated plasma concentration (Cmax) of Apixaban	Up to 26 hours, post dose (from Day 1 to Day 2)
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban	Up to 26 hours, post dose (from Day 1 to Day 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events (AEs)	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Number of participants with Serious Adverse Events (SAEs)	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Vital Signs of body temperature	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Vital Signs of respiratory rate	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Vital Signs of blood pressure	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Vital Signs of heart rate	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Number of participants with abnormalities in Physical Examinations	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of blood serum	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Prothrombin Time (PT) clotting activity during treatment	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Change from baseline in Clinical Laboratory Tests of urine	Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing	Up to 30 Days after last dosing
Pharmacodynamics will be analyzed using anti-Factor Xa activity		Up to 26 hours, post dose (from Day 1 to Day 2)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2013
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 19, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: CV185-118; 2012-001581-15 (EudraCT Number)