EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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