EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis (EINSTEINJr)
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|ClinicalTrials.gov Identifier: NCT02309411|
Recruitment Status : Completed
First Posted : December 5, 2014
Results First Posted : June 13, 2018
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Drug: Rivaroxaban (Xarelto, BAY59-7939)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis|
|Actual Study Start Date :||January 15, 2015|
|Actual Primary Completion Date :||April 5, 2017|
|Actual Study Completion Date :||April 5, 2017|
Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant
- Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events [ Time Frame: During or within 2 days after stop of study treatment (up to 32 days) ]
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, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, 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).
- Number of Subjects With Symptomatic Recurrent Venous Thromboembolism [ Time Frame: From start of the study treatment up to 30-days post study treatment period (approximately 60 days) ]Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test.
- Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging [ Time Frame: At the end of the 30-day treatment period ]The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects.
- Change From Baseline in Prothrombin Time at Specified Time Points [ Time Frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) ]Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline.
- Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points [ Time Frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose) ]The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline.
- Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points [ Time Frame: Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose) ]Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported.
- Anti-factor Xa Values at Specified Time Points [ Time Frame: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose) ]The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309411
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|Study Director:||Bayer Study Director||Bayer|