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

• Status: Terminated
• Trial end date: 2012-07-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborator: Pfizer
• Treatments: Apixaban

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