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

Venous Thromboembolism Clinical Trial

Official title:

Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01195727
• Other study ID #: CV185-079
• Status: Terminated
• Phase: Phase 1
• First received: September 3, 2010
• Last updated: April 6, 2017
• Start date: July 26, 2011
• Est. completion date: July 16, 2012

Study information

• Verified date: April 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 16, 2012
• Est. primary completion date: June 14, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Leuven
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Ottawa	Ontario
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico City	Distrito Federal
Mexico	Local Institution	Mexico, D. F.	Distrito Federal
Mexico	Local Institution	Puebla
Netherlands	Local Institution	Amsterdam
United States	Penn State Hershey Children'S Hospital	Hershey	Pennsylvania
United States	Saint Peter'S University Hospital	New Brunswick	New Jersey
United States	Children'S Hospital Of Orange County	Orange	California
United States	The Toledo Children'S Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Mexico,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis		Days 1, 2, Day 5, 6 or 7

External Links

•   BMS Clinical Trial Education Resource
•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form