EUCTR2014-002385-74-NL进行中（未招募）1 期
7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children from birth to less than 6 months with arterial or venous thrombosis. - EINSTEIN Junior Phase l/ll in children from birth to less than 6 months.
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
- 8
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
- 性别
- All
入选标准
- •1.Children from birth to less than 6 months with documented symptomatic or asymptomatic venous or arterial thrombosis who have been treated with anticoagulant therapy for at least 5 days.
- •2.Gestational age at birth of at least 37 weeks.
- •3.Hemoglobin, platelets, creatinine, ALT and total and direct bilirubin assessed within
- •10 days prior to enrollment.
- •4.Oral feeding/nasogastric/gastric feeding for at least 10 days.
- •5.Informed consent provided.
- •6. Body weight >2600 g.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 8
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Active bleeding or high risk for bleeding contraindicating anticoagulant therapy, including history of intra-ventricular bleeding
- •2.Symptomatic progression of thrombosis during preceding anticoagulant treatment
- •3.Planned invasive procedures, including lumbar puncture and removal of non-peripherally placed central lines during study treatment
- •4.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
- •5.Creatinine > 1.5 times of normal
- •6.Uncontrolled hypertension defined as > 95th percentile.
- •7.History of gastrointestinal disease or surgery associated with impaired absorption
- •8.Platelet count <100 x 109/L
- •9.Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp), e.g. all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)
- •10.Concomitant use of strong inducers of CYP3A4, e.g. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- •11.Indication for anticoagulant therapy other than current thrombosis
- •12.Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID) therapy. Incidental use is allowed.
- •13.Hypersensitivity to rivaroxaban or its excipients
- •14.Participation in a study with an investigational drug or medical device within 30 days prior to enrollment.
研究者
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