The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. There will also be a check for bleeding and worsening of blood clots.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (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, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is 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 * cessation (temporary) 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).
Time frame: From start of study drug administration until end of the 30-day treatment period
Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test.
Time frame: From start of study drug administration until end of the 30-day treatment period
Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available.
Time frame: Repeat imaging at the end of the 30 day treatment period
Change From Baseline in Prothrombin Time at Specified Time Points
Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade.
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Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Los Angeles, California, United States
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Orange, California, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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New Hyde Park, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Columbus, Ohio, United States
...and 49 more locations
Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway.
Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
Anti-factor Xa Values at Specified Time Points
The individual anti-Factor Xa activity was determined ex-vivo using a photometric method.
Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31
Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
Geometric and percentage geometric coefficient of variation (%CV) were reported.
Time frame: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31