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

Bristol-Myers Squibb49 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Thromboembolism

Interventions

ApixabanDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 1 DayMax age: 18 Years

Medical Language ↔ Plain English

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 \[G-tube\])

Locations (27)

Outcomes

Primary Outcomes

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)

Maximum estimated plasma concentration (Cmax) of Apixaban

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

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

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Arkansas Children'S Hospital

Little Rock, Arkansas, United States

Children'S Hospital Of Orange County

Orange, California, United States

Connecticut Children's Medical Center

Hartford, Connecticut, United States

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, United States

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Children's Healthcare Of Atlanta

Atlanta, Georgia, United States

Blank Childrens Hospital

Des Moines, Iowa, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, United States

Children'S Mercy Hospital And Clinics

Kansas City, Missouri, United States

...and 17 more locations

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Up to 30 Days after last dosing

Pharmacodynamics will be analyzed using anti-Factor Xa activity

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