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OpenTrials
Completed

NCT Number: NCT01707394

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

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Parkville, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

Apixaban

Drug

Specified dose on specified days

Other names: BMS-562247

Primary outcomes

  1. Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban

    Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)

  2. Maximum estimated plasma concentration (Cmax) of Apixaban

    Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)

  3. Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban

    Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  3. Change from baseline in Vital Signs of body temperature

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  4. Change from baseline in Vital Signs of respiratory rate

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  5. Change from baseline in Vital Signs of blood pressure

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  6. Change from baseline in Vital Signs of heart rate

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  7. Number of participants with abnormalities in Physical Examinations

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  8. Change from baseline in Clinical Laboratory Tests of blood

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  9. Change from baseline in Clinical Laboratory Tests of blood serum

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  10. Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  11. Change from baseline in International Normalized Ratio (INR) clotting activity during treatment

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  12. Change from baseline in Prothrombin Time (PT) clotting activity during treatment

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  13. Change from baseline in Clinical Laboratory Tests of urine

    Time frame: Up to 30 Days after last dosing

    Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing

  14. Pharmacodynamics will be analyzed using anti-Factor Xa activity

    Time frame: Up to 26 hours, post dose (from Day 1 to Day 2)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 16, 2012
Registry last updated
Mar 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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