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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
Date last updated
29/10/2024
Titles & IDs
Public title
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
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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
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Secondary ID [1]
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2014-002606-20
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Secondary ID [2]
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B0661037
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Composite of Major and Clinically Relevant Non-Major (CRNM) Bleeding
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Assessment method [1]
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Bleeding definitions are based on the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding includes: (i) fatal bleeding; (ii) clinically overt bleeding with a decrease in Hgb of at least 20 g/L (2 g/dL) in 24 hours; (iii) retroperitoneal, pulmonary, intracranial, or central nervous system bleeding; and (iv) bleeding requiring surgical intervention in an operating suite (including interventional radiology). Clinically relevant non-major bleeding includes: (i) overt bleeding requiring a blood product not attributable to the participant's underlying condition; and (ii) bleeding requiring medical or surgical intervention to restore hemostasis, other than in an operating suite.
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Timepoint [1]
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From first dose (Day 1) up to 114 days
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Primary outcome [2]
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Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE) and VTE-Related Mortality
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Assessment method [2]
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Recurrent VTE, defined as either contiguous progression or non-contiguous new thrombus and including, but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE) and paradoxical embolism. 95% CI was from the Agresti-Coull method.
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Timepoint [2]
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From first dose (Day 1) up to 114 days
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Secondary outcome [1]
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Percentage of Participants Who Died
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Assessment method [1]
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Death due to any cause was assessed. 95% CI was calculated using the Agresti-Coull method.
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Timepoint [1]
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From first dose (Day 1) up to 114 days
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Secondary outcome [2]
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Percentage of Participants With Venous Thromboembolism (VTE)-Related Mortality
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Assessment method [2]
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Participants were assessed for death due to Venous Thromboembolism (VTE).
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Timepoint [2]
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From first dose (Day 1) up to 114 days
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Secondary outcome [3]
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Number of Participants With Index Venous Thromboembolism (VTE) Status
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Assessment method [3]
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Index VTE status was defined as the last image obtained during the Main treatment phase for each participant's comparison to baseline imaging. Index VTE status was classified as Recurrence-contiguous; Recurrence-new; Unchanged; Regression; Resolution; Indeterminate/Nondiagnostic. Participants could have multiple concomitant index events. Regression was defined as (ie, unequivocal decrease \[\>50%\] of the total volume/mass of the thrombus compared to the index event)
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Timepoint [3]
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From first dose (Day 1) up to 91 days
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Secondary outcome [4]
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Percentage of Participants With Stroke
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Assessment method [4]
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Participants were assessed for incidence of stroke.
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Timepoint [4]
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From first dose (Day 1) up to 114 days
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Secondary outcome [5]
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Percentage of Participants With Symptomatic and Asymptomatic Recurrent Venous Thromboembolism (VTE)
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Assessment method [5]
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Recurrent VTE, defined as either contiguous progression or non-contiguous new thrombus and including, but not limited to deep vein thrombosis (DVT), pulmonary embolism (PE) and paradoxical embolism. 95% CI was from the Agresti-Coull method.
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Timepoint [5]
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From first dose (Day 1) up to 114 days
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Secondary outcome [6]
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Number of Participants With New Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE)
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Assessment method [6]
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Participants were assessed for incidence of Symptomatic or Asymptomatic Deep Vein Thrombosis (DVT) and New Symptomatic or Asymptomatic Pulmonary Embolism (PE).
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Timepoint [6]
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From first dose (Day 1) up to 114 days
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Secondary outcome [7]
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Percentage of Participants With Other Symptomatic and Asymptomatic Venous Thromboembolism (VTE)
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Assessment method [7]
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Other VTE included events such as cerebral sinovenous thrombosis, renal vein thrombosis, portal vein thrombosis, catheter-related VTE, and splanchnic thrombosis. If VTE event type was blank, it was included in the Other VTE. 95% CI was from the Agresti-Coull method.
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Timepoint [7]
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From first dose (Day 1) up to 114 days
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Secondary outcome [8]
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Number of Participants With Clinically Relevant Non-Major (CRNM) Bleeding, Major Bleeding and Minor Bleeding
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Assessment method [8]
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Bleeding definitions are based on the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding includes: (i) fatal bleeding; (ii) clinically overt bleeding with a decrease in Hgb of at least 20 g/L (2 g/dL) in 24 hours; (iii) retroperitoneal, pulmonary, intracranial, or central nervous system bleeding; and (iv) bleeding requiring surgical intervention in an operating suite (including interventional radiology). Clinically relevant non-major bleeding includes: (i) overt bleeding requiring a blood product not attributable to the participant's underlying condition; and (ii) bleeding requiring medical or surgical intervention to restore hemostasis, other than in an operating suite. Minor bleeding was defined as any overt or macroscopic evidence of bleeding that does not fulfill the above criteria for either major bleeding or clinically relevant, non-major bleeding.
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Timepoint [8]
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From first dose (Day 1) up to 114 days
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Secondary outcome [9]
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Blood Concentration of Apixaban (ng/mL)
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Assessment method [9]
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Blood samples were collected to assess the apixaban concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to =27 days arm. The lower limit of quantification (LLOQ) is 1.0 ng/mL for plasma samples, and 0.5 ng/mL for dried blood samples.
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Timepoint [9]
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3 hour (H), 12 H, 24 H at Day 3; pre and post dose at Day 14 and Day 42
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Secondary outcome [10]
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Concentration of Plasma Anti-Factor Xa (ng/mL)
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Assessment method [10]
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Blood samples were collected to assess the Anti-Factor Xa concentration at specified timepoints. Day 1 PK concentrations were only collected for participants in the Birth to =27 days arm. The lower limit of quantification (LLOQ) is 35.0 ng/mL.
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Timepoint [10]
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Pre and post dose at Day 14 and Day 42
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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.
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Minimum age
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/11/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/04/2024
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Sample size
Target
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Accrual to date
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Final
229
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Kids Cancer Centre - Randwick
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Recruitment hospital [2]
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Prince of Wales Hospital - Sydney
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Recruitment hospital [3]
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The Royal Childrens Hospital - Parkville
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2031 - Sydney
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Recruitment postcode(s) [3]
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3052 - Parkville
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Recruitment outside Australia
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Alabama
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WEST Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Pfizer
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Ethics approval
Ethics application status
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Summary
Brief summary
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
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Trial website
https://clinicaltrials.gov/study/NCT02464969
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT02464969/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT02464969/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02464969
Download to PDF