Clinical trial NCT01195727: Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Official title: Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Venous Thromboembolism
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2010-09-06
Enrollment: 13
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: 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
timeFrame: Days 1, 2, Day 5, 6 or 7 and Day 11
Secondary outcomes:
measure: Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
timeFrame: Days 1, 2, Day 5, 6 or 7
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children'S Hospital Of Orange County
state: California
city: New Brunswick
country: United States
facility: Saint Peter'S University Hospital
state: New Jersey
city: Toledo
country: United States
facility: The Toledo Children'S Hospital
state: Ohio
city: Hershey
country: United States
facility: Penn State Hershey Children'S Hospital
state: Pennsylvania
city: Bruxelles
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico, D. F.
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Puebla
country: Mexico
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: