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

Primary Purpose

Venous Thromboembolism

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Apixaban
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Venous Thromboembolism

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children'S Hospital Of Orange County
  • Saint Peter'S University Hospital
  • The Toledo Children'S Hospital
  • Penn State Hershey Children'S Hospital
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 5A - Apixaban (Low Dose)

Group 5B - Apixaban (High Dose)

Arm Description

Group 5: 12 years to <18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Group 5: 12 years to <18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days

Outcomes

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

Secondary Outcome Measures

Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis

Full Information

First Posted
September 3, 2010
Last Updated
April 6, 2017
Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01195727
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Study Start Date
July 26, 2011 (Actual)
Primary Completion Date
June 14, 2012 (Actual)
Study Completion Date
July 16, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 5A - Apixaban (Low Dose)
Arm Type
Experimental
Arm Description
Group 5: 12 years to <18 years; 0.66 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
Arm Title
Group 5B - Apixaban (High Dose)
Arm Type
Experimental
Arm Description
Group 5: 12 years to <18 years; 1.32 mg/m² Oral solution, Oral, Twice A Day (BID), 10 days
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
BMS-562247
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Evidence of anti-Factor Xa confirmed by analysis of anti-Factor Xa PD analysis
Time Frame
Days 1, 2, Day 5, 6 or 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Saint Peter'S University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
The Toledo Children'S Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Penn State Hershey Children'S Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution
City
Mexico, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
11000
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution
City
Puebla
ZIP/Postal Code
72190
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/pages/home.aspx
Description
BMS Clinical Trial Education Resource

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

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