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

Thromboembolism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707394
• Other study ID #: CV185-118
• Secondary ID: 2012-001581-15
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2013
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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])

Related Conditions & MeSH terms

• Thromboembolism
• Thrombosis

Intervention

Drug:
• Apixaban
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution	Parkville	Victoria
Canada	University of Alberta - Edmonton Clinic Health Academy	Edmonton	Alberta
Canada	Local Institution	Hamilton	Ontario
Canada	The Hospital For Sick Children	Toronto	Ontario
Israel	Local Institution	Ramat Gan
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
United States	Children's Healthcare Of Atlanta	Atlanta	Georgia
United States	Blank Childrens Hospital	Des Moines	Iowa
United States	Duke University Medical Center	Durham	North Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Penn State Hershey Children'S Hospital	Hershey	Pennsylvania
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Children'S Mercy Hospital And Clinics	Kansas City	Missouri
United States	Arkansas Children'S Hospital	Little Rock	Arkansas
United States	Kosair Charities Pediatric Clinical Research Unit	Louisville	Kentucky
United States	Childrens Hospital Of Wisconsin	Milwaukee	Wisconsin
United States	Saint Peter'S University Hospital	New Brunswick	New Jersey
United States	Children'S Hospital Of Orange County	Orange	California
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	ProMedica Toledo Children's Hospital	Toledo	Ohio
United States	Childrens National Medical Center	Washington	District of Columbia
United States	MedStar Georgetown University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban		Up to 26 hours, post dose (from Day 1 to Day 2)
Primary	Maximum estimated plasma concentration (Cmax) of Apixaban		Up to 26 hours, post dose (from Day 1 to Day 2)
Primary	Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban		Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pharmacodynamics will be analyzed using anti-Factor Xa activity		Up to 26 hours, post dose (from Day 1 to Day 2)

External Links

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