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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01195727
First received: September 3, 2010
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Apixaban
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis [ Time Frame: Days 1, 2, Day 5, 6 or 7 ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 5A - Apixaban (Low Dose)

Group 5: 12 years to <18 years;

0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Drug: Apixaban
Other Name: BMS-562247
Experimental: Group 5B - Apixaban (High Dose)

Group 5: 12 years to <18 years;

1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Drug: Apixaban
Other Name: BMS-562247

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195727

Locations
United States, California
Children'S Hospital Of Orange County
Orange, California, United States, 92868
United States, New Jersey
Saint Peter'S University Hospital
New Brunswick, New Jersey, United States, 08901
United States, Ohio
The Toledo Children'S Hospital
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, United States, 17033
Belgium
Local Institution
Bruxelles, Belgium, 1020
Local Institution
Leuven, Belgium, 3000
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Local Institution
Ottawa, Ontario, Canada, K1H 8L1
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 04530
Local Institution
Mexico City, Distrito Federal, Mexico, 14080
Local Institution
Mexico, D. F., Distrito Federal, Mexico, 11000
Local Institution
Guadalajara, Jalisco, Mexico, 44340
Local Institution
Puebla, Mexico, 72190
Netherlands
Local Institution
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01195727     History of Changes
Other Study ID Numbers: CV185-079
Study First Received: September 3, 2010
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
Canada: Therapeutic Products Directorate
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 31, 2014