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Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

Primary Purpose

Thromboembolism

Status
Completed
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 Thromboembolism

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder

  • Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age

    • Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age
    • Neonates: defined as newly born (within 4 weeks)
  • Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system

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
  • Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])

Sites / Locations

  • Arkansas Children'S Hospital
  • Children'S Hospital Of Orange County
  • Connecticut Children's Medical Center
  • MedStar Georgetown University Hospital
  • Childrens National Medical Center
  • Children's Healthcare Of Atlanta
  • Blank Childrens Hospital
  • University of Iowa Hospitals and Clinics
  • Kosair Charities Pediatric Clinical Research Unit
  • Children'S Mercy Hospital And Clinics
  • Saint Peter'S University Hospital
  • Duke University Medical Center
  • ProMedica Toledo Children's Hospital
  • Penn State Hershey Children'S Hospital
  • Childrens Hospital Of Philadelphia
  • Children's Hopsital Of Pittsburgh Of UPMC
  • Children's Hospital Of Pittsburgh Of UPMC
  • Childrens Hospital Of Wisconsin
  • Local Institution
  • University of Alberta - Edmonton Clinic Health Academy
  • Local Institution
  • The Hospital For Sick Children
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1: Apixaban (low dose)

Group 2A: Apixaban (low dose)

Group 2B: Apixaban (low dose)

Group 3: Apixaban (low dose)

Group 4: Apixaban (low dose)

Group 5: Apixaban (low dose)

Group 2A (higher dose): Apixaban (low dose)

Arm Description

Outcomes

Primary Outcome Measures

Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Maximum estimated plasma concentration (Cmax) of Apixaban
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban

Secondary Outcome Measures

Number of participants with Adverse Events (AEs)
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Number of participants with Serious Adverse Events (SAEs)
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Vital Signs of body temperature
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Vital Signs of respiratory rate
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Vital Signs of blood pressure
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Vital Signs of heart rate
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Number of participants with abnormalities in Physical Examinations
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Clinical Laboratory Tests of blood
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Clinical Laboratory Tests of blood serum
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Prothrombin Time (PT) clotting activity during treatment
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Change from baseline in Clinical Laboratory Tests of urine
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Pharmacodynamics will be analyzed using anti-Factor Xa activity

Full Information

First Posted
October 12, 2012
Last Updated
March 19, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01707394
Brief Title
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Official Title
Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Apixaban in Pediatric Subjects at Risk for a Venous or Arterial Thrombotic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2013 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (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
CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for thrombosis

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 2A: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 2B: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 3: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 4: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 5: Apixaban (low dose)
Arm Type
Experimental
Arm Title
Group 2A (higher dose): Apixaban (low dose)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
BMS-562247
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Time Frame
Up to 26 hours, post dose (from Day 1 to Day 2)
Title
Maximum estimated plasma concentration (Cmax) of Apixaban
Time Frame
Up to 26 hours, post dose (from Day 1 to Day 2)
Title
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
Time Frame
Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary Outcome Measure Information:
Title
Number of participants with Adverse Events (AEs)
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Number of participants with Serious Adverse Events (SAEs)
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Vital Signs of body temperature
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Vital Signs of respiratory rate
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Vital Signs of blood pressure
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Vital Signs of heart rate
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Number of participants with abnormalities in Physical Examinations
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Clinical Laboratory Tests of blood
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Clinical Laboratory Tests of blood serum
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Activated partial thromboplastin time (aPTT) clotting activity during treatment
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in International Normalized Ratio (INR) clotting activity during treatment
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Prothrombin Time (PT) clotting activity during treatment
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Change from baseline in Clinical Laboratory Tests of urine
Description
Time Frame: From Day 1 to Day 2 (Up to 26 hours, post dose), and 30 Day after last dosing
Time Frame
Up to 30 Days after last dosing
Title
Pharmacodynamics will be analyzed using anti-Factor Xa activity
Time Frame
Up to 26 hours, post dose (from Day 1 to Day 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Participants with any stable disease that are at risk for a venous or arterial thrombotic disorder Neonates ≥ 34 weeks gestational or ≥ 37 weeks post conceptual age (corrected gestational age) to <18 years of age Gestational and post-conceptual age will only be taken into consideration for eligibility up to 6 months of age Neonates: defined as newly born (within 4 weeks) Participants with any functional CVAD (Central Venous Access Device) in the upper or lower venous system 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 Inability to tolerate oral medication or administration of oral medication via an enteral tube (nasogastric tube [NG tube] or gastronomy tube [G-tube])
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
Arkansas Children'S Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Childrens National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Children's Healthcare Of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Blank Childrens Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Children'S Mercy Hospital And Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
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
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
ProMedica 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
Childrens Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Children's Hopsital Of Pittsburgh Of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Children's Hospital Of Pittsburgh Of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Childrens Hospital Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
University of Alberta - Edmonton Clinic Health Academy
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C9
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
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
44260
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder

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