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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01707394




Registration number
NCT01707394
Ethics application status
Date submitted
12/10/2012
Date registered
16/10/2012
Date last updated
19/08/2020

Titles & IDs
Public title
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Scientific 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
Secondary ID [1] 0 0
2012-001581-15
Secondary ID [2] 0 0
CV185-118
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban

Experimental: Group 1: Apixaban (low dose) -

Experimental: Group 2A: Apixaban (low dose) -

Experimental: Group 2B: Apixaban (low dose) -

Experimental: Group 3: Apixaban (low dose) -

Experimental: Group 4: Apixaban (low dose) -

Experimental: Group 5: Apixaban (low dose) -

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


Treatment: Drugs: Apixaban
Specified dose on specified days

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimated area under the plasma concentration-time curve [AUC(INF)] of Apixaban
Timepoint [1] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Primary outcome [2] 0 0
Maximum estimated plasma concentration (Cmax) of Apixaban
Timepoint [2] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Primary outcome [3] 0 0
Estimated time at which maximum plasma concentration occurs (Tmax) of Apixaban
Timepoint [3] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 30 Days after last dosing
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 30 Days after last dosing
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Up to 30 Days after last dosing
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
Up to 30 Days after last dosing
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to 30 Days after last dosing
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to 30 Days after last dosing
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Up to 30 Days after last dosing
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Up to 30 Days after last dosing
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Up to 30 Days after last dosing
Secondary outcome [10] 0 0
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
Timepoint [10] 0 0
Up to 30 Days after last dosing
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Up to 30 Days after last dosing
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Up to 30 Days after last dosing
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Up to 30 Days after last dosing
Secondary outcome [14] 0 0
Pharmacodynamics will be analyzed using anti-Factor Xa activity
Timepoint [14] 0 0
Up to 26 hours, post dose (from Day 1 to Day 2)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- 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
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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])

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Israel
State/province [16] 0 0
Ramat Gan
Country [17] 0 0
Mexico
State/province [17] 0 0
Distrito Federal
Country [18] 0 0
Mexico
State/province [18] 0 0
Jalisco
Country [19] 0 0
Mexico
State/province [19] 0 0
Nuevo LEON

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT01707394
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications