Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
This study has been terminated.
Sponsor:
Bristol-Myers Squibb
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
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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:
MedlinePlus related topics:
Deep Vein Thrombosis
Drug Information available for:
Apixaban
U.S. FDA Resources
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
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 June 17, 2013