Status:
TERMINATED
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Pfizer
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
12-17 years
Phase:
PHASE1
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 subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 26 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01195727
Start Date
July 26 2011
End Date
July 16 2012
Last Update
April 7 2017
Active Locations (14)
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1
Children'S Hospital Of Orange County
Orange, California, United States, 92868
2
Saint Peter'S University Hospital
New Brunswick, New Jersey, United States, 08901
3
The Toledo Children'S Hospital
Toledo, Ohio, United States, 43606
4
Penn State Hershey Children'S Hospital
Hershey, Pennsylvania, United States, 17033