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

Phase 1

Completed

• Conditions: Thromboembolism
• Interventions: Drug: Apixaban

• Registration Number: NCT01707394
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-12
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-16
• Study Start: 2013-01-10
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2A: Apixaban (low dose)	Apixaban	-
Group 1: Apixaban (low dose)	Apixaban	-
Group 2B: Apixaban (low dose)	Apixaban	-
Group 4: Apixaban (low dose)	Apixaban	-
Group 3: Apixaban (low dose)	Apixaban	-
Group 2A (higher dose): Apixaban (low dose)	Apixaban	-
Group 5: Apixaban (low dose)	Apixaban	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (21)

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Childrens Hospital Of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hopsital Of Pittsburgh Of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Children's Hospital Of Pittsburgh Of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Arkansas Children'S Hospital; 🇺🇸 Little Rock, Arkansas, United States

Blank Childrens Hospital; 🇺🇸 Des Moines, Iowa, United States

Children'S Mercy Hospital And Clinics; 🇺🇸 Kansas City, Missouri, United States

Local Institution; 🇲🇽 Monterrey, Nuevo Leon, Mexico

Saint Peter'S University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Children'S Hospital Of Orange County; 🇺🇸 Orange, California, United States

ProMedica Toledo Children's Hospital; 🇺🇸 Toledo, Ohio, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Childrens Hospital Of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

University of Alberta - Edmonton Clinic Health Academy; 🇨🇦 Edmonton, Alberta, Canada

Children's Healthcare Of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Kosair Charities Pediatric Clinical Research Unit; 🇺🇸 Louisville, Kentucky, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Penn State Hershey Children'S Hospital; 🇺🇸 Hershey, Pennsylvania, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

The Hospital For Sick Children; 🇨🇦 Toronto, Ontario, Canada

Childrens National Medical Center; 🇺🇸 Washington, District of Columbia, United States