Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
1 other identifier
interventional
13
5 countries
14
Brief Summary
CV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2011
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2010
CompletedFirst Posted
Study publicly available on registry
September 6, 2010
CompletedStudy Start
First participant enrolled
July 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2012
CompletedApril 7, 2017
April 1, 2017
11 months
September 3, 2010
April 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic (PK): Model-derived population & individual PK parameters (e.g., CL/F, Vc/F, KA) used to estimate steady state Cmax & AUC(TAU), Cmin & Tmax in each subject. Population PK model will be developed using plasma concentration vs time data
Days 1, 2, Day 5, 6 or 7 and Day 11
Secondary Outcomes (1)
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
Days 1, 2, Day 5, 6 or 7
Study Arms (2)
Group 5A - Apixaban (Low Dose)
EXPERIMENTALGroup 5: 12 years to \<18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
Group 5B - Apixaban (High Dose)
EXPERIMENTALGroup 5: 12 years to \<18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with chronic stable disease with any type of functioning CVC in the upper or lower venous system (e.g., jugular, subclavian; femoral vein) that is anticipated to remain in the subject for the treatment portion of the study.
- \> 12 to \<18 years of age
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Pfizercollaborator
Study Sites (14)
Children'S Hospital Of Orange County
Orange, California, 92868, United States
Saint Peter'S University Hospital
New Brunswick, New Jersey, 08901, United States
The Toledo Children'S Hospital
Toledo, Ohio, 43606, United States
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, 17033, United States
Local Institution
Brussels, 1020, Belgium
Local Institution
Leuven, 3000, Belgium
Local Institution
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
Ottawa, Ontario, K1H 8L1, Canada
Local Institution
Guadalajara, Jalisco, 44340, Mexico
Local Institution
Mexico City, Mexico City, 04530, Mexico
Local Institution
Mexico City, Mexico City, 14080, Mexico
Local Institution
Mexico, D. F., Mexico City, 11000, Mexico
Local Institution
Puebla City, Puebla, 72190, Mexico
Local Institution
Amsterdam, 1105 AZ, Netherlands
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
September 3, 2010
First Posted
September 6, 2010
Study Start
July 26, 2011
Primary Completion
June 14, 2012
Study Completion
July 16, 2012
Last Updated
April 7, 2017
Record last verified: 2017-04