Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Overview[ - collapse ][ - ]
| 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 | Venous Thromboembolism |
| Intervention | Drug: Apixaban |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Responsible Party | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier | NCT01195727 |
| First Received | September 3, 2010 |
| Last Updated | December 27, 2012 |
| Last verified | December 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 3, 2010 |
|---|---|
| Last Updated Date | December 27, 2012 |
| Start Date | July 2011 |
| Estimated Primary Completion Date | July 2012 |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter |
|---|---|
| Official Title | Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label |
| Condition | Venous Thromboembolism |
| Intervention | Drug: Apixaban Other Names: BMS-562247 |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Terminated |
|---|---|
| Estimated Enrollment | 8 |
| Estimated Completion Date | July 2012 |
| Estimated Primary Completion Date | July 2012 |
| Eligibility 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 |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Belgium, Canada, Mexico, Netherlands |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01195727 |
|---|---|
| Other Study ID Numbers | CV185-079 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Bristol-Myers Squibb |
| Study Sponsor | Bristol-Myers Squibb |
| Collaborators | Pfizer |
| Investigators | Study Director: Bristol-Myers Squibb Bristol-Myers Squibb |
| Verification Date | December 2012 |
Locations[ + expand ][ + ]
| Children'S Hospital Of Orange County | Orange, California, United States, 92868 |
|---|---|
| Saint Peter'S University Hospital | New Brunswick, New Jersey, United States, 08901 |
| The Toledo Children'S Hospital | Toledo, Ohio, United States, 43606 |
| Penn State Hershey Children'S Hospital | Hershey, Pennsylvania, United States, 17033 |
| Local Institution | Bruxelles, Belgium, 1020 |
| Local Institution | Leuven, Belgium, 3000 |
| Local Institution | Edmonton, Alberta, Canada, T6G 2B7 |
| Local Institution | Ottawa, Ontario, Canada, K1H 8L1 |
| 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 |
| Local Institution | Amsterdam, Netherlands, 1105 AZ |