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
2 other identifiers
interventional
49
5 countries
27
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2013
Longer than P75 for phase_1
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedStudy Start
First participant enrolled
January 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedMarch 22, 2021
March 1, 2021
7.5 years
October 12, 2012
March 19, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (14)
Number of participants with Adverse Events (AEs)
Up to 30 Days after last dosing
Number of participants with Serious Adverse Events (SAEs)
Up to 30 Days after last dosing
Change from baseline in Vital Signs of body temperature
Up to 30 Days after last dosing
Change from baseline in Vital Signs of respiratory rate
Up to 30 Days after last dosing
Change from baseline in Vital Signs of blood pressure
Up to 30 Days after last dosing
- +9 more secondary outcomes
Study Arms (7)
Group 1: Apixaban (low dose)
EXPERIMENTALGroup 2A: Apixaban (low dose)
EXPERIMENTALGroup 2B: Apixaban (low dose)
EXPERIMENTALGroup 3: Apixaban (low dose)
EXPERIMENTALGroup 4: Apixaban (low dose)
EXPERIMENTALGroup 5: Apixaban (low dose)
EXPERIMENTALGroup 2A (higher dose): Apixaban (low dose)
EXPERIMENTALInterventions
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 \[G-tube\])
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (27)
Arkansas Children'S Hospital
Little Rock, Arkansas, 72202-3591, United States
Children'S Hospital Of Orange County
Orange, California, 92868, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Childrens National Medical Center
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare Of Atlanta
Atlanta, Georgia, 30322, United States
Blank Childrens Hospital
Des Moines, Iowa, 50309, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, 40202, United States
Children'S Mercy Hospital And Clinics
Kansas City, Missouri, 64108, United States
Saint Peter'S University Hospital
New Brunswick, New Jersey, 08901, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
ProMedica Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, 17033, United States
Childrens Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Children's Hopsital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Children's Hospital Of Pittsburgh Of UPMC
Pittsburgh, Pennsylvania, 15224, United States
Childrens Hospital Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Local Institution
Parkville, Victoria, 3052, Australia
University of Alberta - Edmonton Clinic Health Academy
Edmonton, Alberta, T6G 1C9, Canada
Local Institution
Hamilton, Ontario, L8S 4K1, Canada
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8, Canada
Local Institution
Ramat Gan, 52621, Israel
Local Institution
Guadalajara, Jalisco, 44260, Mexico
Local Institution
Mexico City, Mexico City, 04530, Mexico
Local Institution
Mexico City, Mexico City, 14080, Mexico
Local Institution
Monterrey, Nuevo León, 64460, Mexico
Related Publications (1)
Merali SJ, Byon W, Patel YT, Elsrougy A, Marchisin D, Perera V, Chen W, He B, Murthy B. Evaluation of safety, pharmacokinetics, and pharmacodynamics of apixaban in pediatric subjects at risk of venous or arterial thrombotic disorder. CPT Pharmacometrics Syst Pharmacol. 2023 Apr;12(4):500-512. doi: 10.1002/psp4.12935. Epub 2023 Mar 5.
PMID: 36861188DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2012
First Posted
October 16, 2012
Study Start
January 10, 2013
Primary Completion
June 30, 2020
Study Completion
June 30, 2020
Last Updated
March 22, 2021
Record last verified: 2021-03