EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
Condition: Venous Thromboembolism
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Intervention description: 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
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Pediatric

Summary:

      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.
    

Eligibility criteria:

        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