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 catheter-related arterial or venous thrombosis - EINSTEIN Junior Phase l/ll in children from birth to less than 6 months

BAYER HEALTHCARE AG0 个研究点目标入组 8 人开始时间: 2018年3月2日最近更新: 2018年3月12日

适应症

试验速览

暂无简介。

•1.Children from birth to less than 6 months with documented symptomatic or asymptomatic catheter-related venous or arterial thrombosis who will enter their last 7 days of intended anticoagulant treatment.2.Gestational age at birth of at least 37 weeks.3.Hemoglobin, platelets assessed within 10 days prior to enrollment.4.Oral feeding/nasogastric/gastric feeding for at least 10 days. 5.Informed consent provided.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 1
•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, including history of intra-ventricular bleeding.2.Symptomatic progression of thrombosis during preceding anticoagulant treatment.3.Planned invasive procedures, including lumbar puncture and removalof non-peripherally placed central lines during study treatment.4.Known hepatic disease associated with coagulopathy leading to a clinically relevant bleeding risk.Creatinine > 1.5 times the baseline value in children aged 1 month and older and creatinine > 1.5 mg/dl in children younger than 1 month5. Hypertension defined as 6.History of gastrointestinal disease or surgery associated with impaired absorption.7.Platelet count < 100 x 109/L.8.Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4) and P-glycoprotein (P-gp).9.Concomitant use of strong inducers of CYP3A4.10.Indication for anticoagulant therapy other than current thrombosis.11.Indication for antiplatelet therapy or NSAID therapy.12.Hypersensitivity to rivaroxaban or its excipients.13.Participation in a study with an investigational drug or medical device within 30 days prior to enrollment

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