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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-26

Study Completion Date

2012-07-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Interventions

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Apixaban

Intervention Type DRUG

Other Intervention Names

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BMS-562247

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No