Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
With
Janssen Research & Development, LLC
Age
0–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Children aged 6 months to \< 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
Informed consent provided
You may not be if
Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
An estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
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 10\*9/L
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), i.e. 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, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
Inability to cooperate with the study procedures
Previous randomization to this study
Participation in a study with an investigational drug or medical device within 30 days prior to randomization
Clareo Health | EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
