Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Phase 1

Terminated

• Conditions: Venous Thromboembolism
• Interventions: Drug: Apixaban

• Registration Number: NCT01195727
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Study Start: 2011-07-26
• Primary Completion: 2012-06-14
• Study Completion: 2012-07-16
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 5A - Apixaban (Low Dose)	Apixaban	Group 5: 12 years to \<18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
Group 5B - Apixaban (High Dose)	Apixaban	Group 5: 12 years to \<18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis	Days 1, 2, Day 5, 6 or 7

Trial Locations

Locations (5)

The Toledo Children'S Hospital; 🇺🇸 Toledo, Ohio, United States

Penn State Hershey Children'S Hospital; 🇺🇸 Hershey, Pennsylvania, United States

Children'S Hospital Of Orange County; 🇺🇸 Orange, California, United States

Local Institution; 🇳🇱 Amsterdam, Netherlands

Saint Peter'S University Hospital; 🇺🇸 New Brunswick, New Jersey, United States