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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
13
Children'S Hospital Of Orange County
Orange, California, United States
Saint Peter'S University Hospital
New Brunswick, New Jersey, United States
The Toledo Children'S Hospital
Toledo, Ohio, United States
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
Time frame: Days 1, 2, Day 5, 6 or 7 and Day 11
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
Time frame: Days 1, 2, Day 5, 6 or 7
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Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, United States
Local Institution
Brussels, Belgium
Local Institution
Leuven, Belgium
Local Institution
Edmonton, Alberta, Canada
Local Institution
Ottawa, Ontario, Canada
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
...and 4 more locations