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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02234843
Registration number
NCT02234843
Ethics application status
Date submitted
5/09/2014
Date registered
9/09/2014
Date last updated
1/04/2020
Titles & IDs
Public title
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
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Scientific title
Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism
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Secondary ID [1]
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2014-000565-47
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Secondary ID [2]
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14372
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Universal Trial Number (UTN)
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Trial acronym
EINSTEIN Jr
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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 - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Standard of Care
Experimental: BAY59-7939 - Rivaroxaban (tablets and oral suspension) Dose: Age and body weight-adjusted dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban.
Experimental: Standard of Care - Subcutaneous low molecular weight heparin (LMWH), subcutaneous fondaparinux and/or oral vitamin K antagonist (VKA) Dose : as per standard of care
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension
Treatment: Drugs: Standard of Care
LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.
dose : as per standard of care
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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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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
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Assessment method [1]
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The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
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Timepoint [1]
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During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)
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Primary outcome [2]
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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
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Assessment method [2]
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The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
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Timepoint [2]
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During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
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Primary outcome [3]
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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period
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Assessment method [3]
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Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population.
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Timepoint [3]
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During extended treatment period: up to month 12.
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Primary outcome [4]
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Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and = 30 Days After Stop of Study Medication)
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Assessment method [4]
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The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported.
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Timepoint [4]
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More than 2 and up to 30 days after stop of study medication
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Primary outcome [5]
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Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period
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Assessment method [5]
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The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization).
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Timepoint [5]
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During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
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Primary outcome [6]
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Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period
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Assessment method [6]
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Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life.
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Timepoint [6]
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During extended treatment period: up to month 12.
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Secondary outcome [1]
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Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period
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Assessment method [1]
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The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population
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Timepoint [1]
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During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)
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Secondary outcome [2]
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AUC(0-24)ss in Plasma
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Assessment method [2]
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AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state.
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Timepoint [2]
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over 24 hours
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Secondary outcome [3]
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Cmax,ss in Plasma
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Assessment method [3]
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Maximum drug concentration in measured matrix at steady state during a dosage interval
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Timepoint [3]
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0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)
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Secondary outcome [4]
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Ctrough,ss in Plasma
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Assessment method [4]
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Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state
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Timepoint [4]
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0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)
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Secondary outcome [5]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
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Assessment method [5]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [5]
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Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
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Secondary outcome [6]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [6]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [6]
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Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
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Secondary outcome [7]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [7]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [7]
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Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
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Secondary outcome [8]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [8]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
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Timepoint [8]
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Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
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Secondary outcome [9]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [9]
0
0
Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
Query!
Timepoint [9]
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Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60
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Secondary outcome [10]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [10]
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0
Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [10]
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Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
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Secondary outcome [11]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [11]
0
0
Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [11]
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Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
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Secondary outcome [12]
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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
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Assessment method [12]
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0
Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds.
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Timepoint [12]
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Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60
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Secondary outcome [13]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
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Assessment method [13]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [13]
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Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [14]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [14]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [14]
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Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [15]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [15]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [15]
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Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [16]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [16]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
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Timepoint [16]
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Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [17]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [17]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated.
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Timepoint [17]
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Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [18]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [18]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [18]
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Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
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Secondary outcome [19]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [19]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [19]
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Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
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Secondary outcome [20]
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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
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Assessment method [20]
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The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds.
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Timepoint [20]
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Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
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Secondary outcome [21]
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Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
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Assessment method [21]
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This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
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Timepoint [21]
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Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
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Secondary outcome [22]
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Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [22]
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This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
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Timepoint [22]
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Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90
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Secondary outcome [23]
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Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
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Assessment method [23]
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This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
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Timepoint [23]
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Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
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Secondary outcome [24]
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0
Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [24]
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0
This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
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Timepoint [24]
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Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90
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Secondary outcome [25]
0
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Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [25]
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0
This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
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Timepoint [25]
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0
Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60
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Secondary outcome [26]
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0
Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
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Assessment method [26]
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0
This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
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Timepoint [26]
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0
Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90
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Secondary outcome [27]
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0
Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
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Assessment method [27]
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0
This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated.
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Timepoint [27]
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Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days
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Secondary outcome [28]
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0
Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
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Assessment method [28]
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0
This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method.
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Timepoint [28]
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Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60
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Eligibility
Key inclusion criteria
- Children aged birth to < 18 years with confirmed venous thromboembolism who receive
initial treatment with therapeutic dosages of UFH (unfractionated heparin), LMWH (low
molecular weight heparin) or fondaparinux and require anticoagulant therapy for at
least 90 days. However, children aged birth to < 2 years with catheter-related
thrombosis require anticoagulant therapy for at least 30 days.
- For children younger than 6 months:
- Gestational age at birth of at least 37 weeks.
- Oral feeding/nasogastric/gastric feeding for at least 10 days.
- Body weight =2600 g
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Minimum age
No limit
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Maximum age
17
Years
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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
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m*2 (in children
younger than 1 year, serum creatinine results above 97.5th percentile excludes
participation)
- Hepatic disease which is associated with either: coagulopathy leading to a clinically
relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x
ULN with direct bilirubin > 20% of the total
- Platelet count < 50 x 109/L
- Sustained uncontrolled hypertension defined as > 95th age percentile
- Life expectancy < 3 months
- Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)
and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency
virus protease inhibitors and the following azole antimycotics agents: ketoconazole,
itraconazole, voriconazole, posaconazole, if used systemically
- Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin,
rifabutin, phenobarbital, phenytoin and carbamazepine
- Childbearing potential without proper contraceptive measures, pregnancy or breast
feeding
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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
Parallel
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Other design features
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Phase
Phase 3
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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
13/11/2014
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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
30/01/2019
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Sample size
Target
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Accrual to date
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Final
500
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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- Parkville
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Recruitment hospital [2]
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- South Brisbane
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Recruitment postcode(s) [1]
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0
3052 - Parkville
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Recruitment postcode(s) [2]
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0
4101 - South Brisbane
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Illinois
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Indiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Missouri
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Country [10]
0
0
United States of America
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North Carolina
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Austria
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Austria
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Bruxelles - Brussel
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Edegem
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Sao Paulo
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Canada
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China
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Zhejiang
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China
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Beijing
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China
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Turku
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France
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France
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Paris
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France
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Germany
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Bayern
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Germany
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Germany
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Germany
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Israel
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Israel
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Jerusalem
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Italy
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Lombardia
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Italy
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Piemonte
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Italy
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Japan
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Japan
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Tokyo
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Netherlands
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Amsterdam
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Groningen
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Portugal
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Lisboa
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Nizhny Novgorod
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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St. Petersburg
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Russian Federation
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Volgograd
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Russian Federation
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Yekaterinburg
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Singapore
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Singapore
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Slovakia
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Bratislava
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Spain
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Barcelona
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Spain
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A Coruña
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Solna
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Bern
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Switzerland
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Luzern
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Switzerland
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Zürich
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Turkey
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Adana
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Turkey
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Istanbul
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Turkey
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Konya
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United Kingdom
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Tyne And Wear
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United Kingdom
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West Yorkshire
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United Kingdom
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Cardiff
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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United Kingdom
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London
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United Kingdom
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Manchester
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Oxford
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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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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Janssen Research & Development, LLC
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to
standard of care in children with acute venous thromboembolism.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02234843
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02234843
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