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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02464969




Registration number
NCT02464969
Ethics application status
Date submitted
26/05/2015
Date registered
8/06/2015

Titles & IDs
Public title
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Scientific title
A Randomized, Open-Label, Active Controlled, Safety and Descriptive Efficacy Study in Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event
Secondary ID [1] 0 0
2014-002606-20
Secondary ID [2] 0 0
B0661037
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous 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

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

Experimental: Apixaban - Subjects between birth to \<18 years will be dosed on a body weight tiered regimen. Subjects =35kg will receive 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;\<35kg to 25kg will receive 8mg BID for 7 days followed by 4mg BID thereafter;\<25 to 18kg will receive 6mg BID for 7 days and then 3mg BID thereafter;\<18 to 12kg will receive 4mg BID for 7 days and then 2mg BID thereafter;\<12 to 9kg will receive 3mg BID for 7 days and then 1.5mg BID thereafter;\< 9kg to 6kg will receive 2 mg BID for 7 days and 1mg BID thereafter;\<6kg to 5kg will receive 1mg BID for 7 days and 0.5mg BID thereafter;\<5kg to 4kg will receive 0.6mg twice daily for 7 days and 0.3mg BID thereafter;PK cohort neonates = 2.6kg will receive 0.1mg BID. Dose will be adjusted as determined by PK measurements (ie, to 0.2mg BID, 0.1mg daily or dose will stay the same).For the post PK cohort Neonates ?4kg to 2.6kg, if confirmed by PK sub analysis,subjects will receive 0.2mg BID for 7 days and 0.1mg BID thereafter.


Treatment: Drugs: Apixaban
Tablet or Solution

Treatment: Drugs: Standard of Care
Unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For subjects under 2 years of age, standard of care will be limited to unfractionated heparin or low molecular weight heparin.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding
Timepoint [1] 0 0
From first dose (Day 1) up to 114 days
Primary outcome [2] 0 0
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality
Timepoint [2] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [1] 0 0
Percentage of Participants Who Died
Timepoint [1] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [2] 0 0
Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality
Timepoint [2] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [3] 0 0
Number of Participants With Index Venous Thromboembolism (VTE) Status
Timepoint [3] 0 0
From first dose (Day 1) up to 91 days
Secondary outcome [4] 0 0
Percentage of Participants With Stroke
Timepoint [4] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [5] 0 0
Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE)
Timepoint [5] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [6] 0 0
Number of Participants With New Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE)
Timepoint [6] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [7] 0 0
Percentage of Participants With Other Symptomatic and Asymptomatic Venous Thromboembolism (VTE)
Timepoint [7] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [8] 0 0
Number of Participants With Clinically Relevant Non-Major (CRNM) Bleeding, Major Bleeding and Minor Bleeding
Timepoint [8] 0 0
From first dose (Day 1) up to 114 days
Secondary outcome [9] 0 0
Blood Concentration of Apixaban (ng/mL)
Timepoint [9] 0 0
3 hour (H), 12 H, 24 H at Day 3; pre and post dose at Day 14 and Day 42
Secondary outcome [10] 0 0
Concentration of Plasma Anti-Factor Xa (ng/mL)
Timepoint [10] 0 0
Pre and post dose at Day 14 and Day 42

Eligibility
Key inclusion criteria
1. Birth to <18 years of age with a minimum weight of 2.6 kg at the time of randomization.
2. Presence of an index VTE which is confirmed by imaging.
3. Intention to manage the index VTE with anticoagulation treatment for at least 6 to 12 weeks.
4. Subjects able to tolerate oral feeding, nasogastric (NG), gastric (G) feeding and are currently tolerating enteric medications, as per investigator's judgement.
Minimum age
0 Days
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Anticoagulant treatment for the index VTE for greater than 14 days prior to randomization. Neonates that are enrolled into the PK cohort must be on a minimum of 5 days and a maximum of 14 days SOC anticoagulation prior to randomization. Neonates that are enrolled into the post PK cohort may receive SOC anticoagulation for up to 14 days prior to randomization.
2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index VTE.
3. A mechanical heart valve.
4. Active bleeding or high risk of bleeding at the time of randomization.
5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to randomization.
6. Abnormal baseline liver function at randomization.
7. Inadequate renal function at the time of randomization.
8. Platelet count <50×109 per L at randomization.
9. Uncontrolled severe hypertension at the time of randomization.
10. Use of prohibited concomitant medication at the time of randomization.
11. Female subjects who are either pregnant or breastfeeding a child.
12. Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment.
13. Unable to take oral or enteric medication via the NG or G tube.
14. Known inherited or acquired antiphospholipid syndrome (APS).
15. Known inherited bleeding disorder or coagulopathy with increased bleeding risk (eg, hemophilia, von Willebrand disease, etc.)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Single group
Other design features
Phase
Phase 4
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
22/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2024
Sample size
Target
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Kids Cancer Centre - Randwick
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
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Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
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United States of America
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Iowa
Country [13] 0 0
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Kentucky
Country [14] 0 0
United States of America
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Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
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State/province [19] 0 0
New York
Country [20] 0 0
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North Carolina
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North Dakota
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Ohio
Country [23] 0 0
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Oklahoma
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United States of America
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Pennsylvania
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State/province [25] 0 0
South Carolina
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Tennessee
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Texas
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Utah
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Washington
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United States of America
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Wisconsin
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Austria
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Tyrol
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Austria
State/province [32] 0 0
Innsbruck
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Austria
State/province [33] 0 0
Wien
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Canada
State/province [34] 0 0
Alberta
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Canada
State/province [35] 0 0
Ontario
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Canada
State/province [36] 0 0
Quebec
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France
State/province [37] 0 0
Marseille
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France
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Montpellier Cedex 5
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France
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Paris
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France
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PESSAC Cedex
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Germany
State/province [41] 0 0
Berlin
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Germany
State/province [42] 0 0
Essen
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Germany
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Munchen
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Israel
State/province [44] 0 0
Jerusalem
Country [45] 0 0
Mexico
State/province [45] 0 0
Jalisco
Country [46] 0 0
Mexico
State/province [46] 0 0
Mexico City
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Republic Tatarstan
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Sverdlovsk Region
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
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Spain
State/province [50] 0 0
Barcelona
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Spain
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Madrid
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Izmir
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Ukraine
State/province [55] 0 0
Dnipro
Country [56] 0 0
Ukraine
State/province [56] 0 0
Zaporizhzhia
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Scotland
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Tyne & Wear
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Wales
Country [60] 0 0
United Kingdom
State/province [60] 0 0
WEST Midlands

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02464969