EUCTR2014-000565-47-SK进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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: 170
- •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
排除标准
- •1. Active bleeding or bleeding risk contraindicating anticoagulant therapy
- •2. An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- •3. Hepatic disease which is associated either: with 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. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure > 95th age percentile
- •6. Life expectancy < 3 months
- •7. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), including but not limited to all human immunodeficiency virus protease Inhibitors and the follwoing azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed). For exceptions, see Section 4.4 of the Study Protocol.
- •8. Concomitant use of strong inducers of CYP3A4, including but not limited to 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. Previous assignment to treatment during this study
- •13. Participation in a study with an investigational drug or medical device within 30 days prior to randomization
研究者
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