Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism - EINSTEIN Junior Phase III: oral rivaroxaban in young children with venous thrombosis

Bayer HealthCare AG0 个研究点目标入组 500 人开始时间: 2014年6月24日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. Children aged 6 months to < 18 years with confirmed venous thromboembolism who receive initial treatment with therapeutic dosages of UFH, LMWH or fondaparinux and require anticoagulant therapy for at least 90 days.
•2. Informed consent provided and, if applicable, child assent provided
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
•2. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
•3. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total
•4. Platelet count < 50 x 109/L
•5. Hypertension defined as > 95th age percentile a
•6. Life expectancy < 3 months
•7. 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
•8. Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
•9. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding
•10. Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
•11. Inability to cooperate with the study procedures
•12. Participation in a study with an investigational drug or medical device within 30 days prior to randomization

发起方