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: 2015年1月26日最近更新: 2018年3月19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: 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

•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 nonperipherally
•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. 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).
•10. Concomitant use of strong inducers of CYP3A4.
•11. Indication for anticoagulant therapy other than current thrombosis.
•12. Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID)
•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.

发起方