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

Phase 1

Conditions: Prevention of VTE in pediatric subject with a central venous cathether.
MedDRA version: 14.0Level: LLTClassification code 10043628Term: Thrombosis NOSSystem Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.0Level: LLTClassification code 10066899Term: Venous thromboembolismSystem Organ Class: 10047065 - Vascular disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-024597-19-NL

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 60

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.
•Neonates > 37 weeks gestation at birth to <18 years of age

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: CV185079 is a multiple dose Apixaban 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 cathether.;Secondary Objective: • To assess the safety and tolerability of multiple doses of Apixaban in pediatric subjects<br>• To assess the pharmacodynamics (PD) of multiple doses of Apixaban on PD marker of anti-factor Xa<br>activity in pediatric subjects;Primary end point(s): CV185079 is a multiple dose Apixaban 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 cathether.;Timepoint(s) of evaluation of this end point: Days 1, 2, 11 and one of the following days: 5, 6 or 7

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis ;Timepoint(s) of evaluation of this end point: Days 1, 2, 11 and one of the following days: 5, 6 or 7