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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01195727
First Posted: September 6, 2010
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 ]

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 ]

Enrollment: 13
Actual Study Start Date: July 26, 2011
Study Completion Date: July 16, 2012
Primary Completion Date: June 14, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 City, Distrito Federal, Mexico, 14080
Local Institution
Mexico, D. F., Distrito Federal, Mexico, 11000
Local Institution
Mexico, Distrito Federal, Mexico, 04530
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:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01195727     History of Changes
Other Study ID Numbers: CV185-079
First Submitted: September 3, 2010
First Posted: September 6, 2010
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Apixaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants