check_circleStudy Completed
Venous Thromboembolism
Bayer Identifier:
14374
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
EINSTEIN Junior Phase II: oral rivaroxaban in young children with venous thrombosis
Trial purpose
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. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
Key Participants Requirements
Sex
BothAge
6 - 5 YearsTrial summary
Enrollment Goal
46Trial Dates
January 2015 - April 2017Phase
Phase 2Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Wien, 1090, Austria | |
Withdrawn | Innsbruck, 6020, Austria | |
Withdrawn | Graz, 8036, Austria | |
Withdrawn | Linz, 4020, Austria | |
Completed | Chicago, 60611, United States | |
Withdrawn | Los Angeles, 90095, United States | |
Withdrawn | Miami, 33155, United States | |
Completed | Children's Healthcare of Atlanta | Atlanta, 30322, United States |
Withdrawn | Philadelphia, 19104-4399, United States | |
Completed | Gainesville, 32610, United States | |
Completed | Indianapolis, 46202, United States | |
Withdrawn | Los Angeles, 90027-6089, United States | |
Withdrawn | Lansing, 48912, United States | |
Completed | Bern, 3010, Switzerland | |
Withdrawn | Luzern, 6000, Switzerland | |
Completed | Parkville, 3052, Australia | |
Completed | St. Petersburg, 197022, Russia | |
Withdrawn | Kirov, 610027, Russia | |
Withdrawn | Sankt-Peterburg, 197110, Russia | |
Withdrawn | Moscow, 119049, Russia | |
Completed | Nizhny Novgorod, 603136, Russia | |
Withdrawn | Krasnodar, 350013, Russia | |
Withdrawn | Yekaterinburg, 620149, Russia | |
Withdrawn | Kansas City, 64108-9898, United States | |
Withdrawn | Jacksonville, 32207, United States | |
Withdrawn | Fort Worth, 76104, United States | |
Withdrawn | São Paulo, Brazil | |
Withdrawn | Lübeck, 23538, Germany | |
Withdrawn | Berlin, 13353, Germany | |
Withdrawn | Halle, 06120, Germany | |
Completed | Newcastle Upon Tyne, NE1 4LP, United Kingdom | |
Withdrawn | Glasgow, G51 4TF, United Kingdom | |
Withdrawn | Esplugues de LLobregat, 08950, Spain | |
Withdrawn | AMSTERDAM, 1105 AZ, Netherlands | |
Withdrawn | UTRECHT, 3584 CX, Netherlands | |
Completed | NIJMEGEN, 6525 GA, Netherlands | |
Withdrawn | AMSTERDAM, 1081 HV, Netherlands | |
Withdrawn | ROTTERDAM, 3015 CE, Netherlands | |
Withdrawn | Belo Horizonte, 30130-100, Brazil | |
Completed | São Paulo, Brazil | |
Withdrawn | Campinas, 130839 970, Brazil | |
Completed | São Paulo, 01227-200, Brazil | |
Completed | Birmingham, B4 6NH, United Kingdom | |
Withdrawn | Manchester, M13 9WL, United Kingdom | |
Completed | Milano, 20122, Italy | |
Completed | Torino, 10126, Italy | |
Completed | Cardiff, CF14 4XW, United Kingdom | |
Completed | Valencia, 46026, Spain | |
Completed | Barcelona, 08035, Spain | |
Withdrawn | A Coruña, 15006, Spain | |
Withdrawn | Madrid, 28046, Spain | |
Withdrawn | Sevilla, 41013, Spain | |
Withdrawn | MONTPELLIER, 34059, France | |
Withdrawn | PARIS, 75015, France | |
Withdrawn | BORDEAUX, 33000, France | |
Withdrawn | TOULOUSE Cedex 9, 31059, France | |
Withdrawn | Frankfurt, 60590, Germany | |
Completed | Pensacola, 32504, United States | |
Terminated | Olsztyn, 10-561, Poland | |
Withdrawn | Lodz, 91-738, Poland | |
Withdrawn | BRUXELLES - BRUSSEL, 1200, Belgium | |
Withdrawn | EDEGEM, 2650, Belgium | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Jerusalem, 9112001, Israel | |
Withdrawn | Petach Tikva, 4920235, Israel | |
Completed | Padova, 35128, Italy | |
Withdrawn | Cork, Ireland | |
Withdrawn | Freiburg, 79106, Germany | |
Withdrawn | Hamilton, L8N 3Z5, Canada | |
Completed | Toronto, M5G 1X8, Canada | |
Completed | Setagaya, 157-8535, Japan | |
Withdrawn | Fuchu, 183-8561, Japan | |
Withdrawn | Moscow, 117997, Russia | |
Completed | Moscow, 117997, Russia | |
Withdrawn | Ottawa, K1H 8L1, Canada | |
Withdrawn | Afula, 1834111, Israel | |
Withdrawn | Las Vegas, 89109, United States | |
Withdrawn | Pavia, 27100, Italy | |
Withdrawn | Bahia Blanca, B8001HXM, Argentina | |
Withdrawn | Buenos Aires, C1425EFD, Argentina | |
Withdrawn | LEUVEN, 3000, Belgium | |
Withdrawn | Madrid, 28007, Spain | |
Withdrawn | Budapest, 1094, Hungary | |
Completed | Budapest, 1097, Hungary | |
Withdrawn | HUS, 00029, Finland | |
Withdrawn | Turku, 20520, Finland | |
Terminated | Gdansk, 80-952, Poland | |
Withdrawn | LILLE, 59037, France |
Primary Outcome
- Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding EventsMajor 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).date_rangeTime Frame:During or within 2 days after stop of study treatment (up to 32 days)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Number of Subjects With Symptomatic Recurrent Venous ThromboembolismVenous 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.date_rangeTime Frame:From start of the study treatment up to 30-days post study treatment period (approximately 60 days)enhanced_encryptionNoSafety Issue:
- Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat ImagingThe 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.date_rangeTime Frame:At the end of the 30-day treatment periodenhanced_encryptionNoSafety Issue:
- Change From Baseline in Prothrombin Time at Specified Time PointsProthrombin 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.date_rangeTime Frame:Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)enhanced_encryptionNoSafety Issue:
- Change From Baseline in Activated Partial Thromboplastin Time at Specified Time PointsThe 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.date_rangeTime Frame:Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)enhanced_encryptionNoSafety Issue:
- Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time PointsConcentration 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.date_rangeTime 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)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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