30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
研究概览
简要总结
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events. There will also be a check for worsening of blood clots.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to < 6 years who have been treated for at least 2 months or, in case of catheter related thrombosis, for at least 6 weeks with LMWH (low molecular weight heparin), fondaparinux and/or VKA (vitamin K antagonist) for documented symptomatic or asymptomatic venous thrombosis - Hemoglobin, platelets, creatinine, alanine aminotransferase (ALT) and bilirubin evaluated within 10 days prior to randomization
- •Informed consent provided
排除标准
- •Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- •Symptomatic progression of venous thrombosis during preceding anticoagulant treatment
- •Planned invasive procedures, including lumbar puncture and removal of non peripherally placed central lines during study treatment
- •An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
- •Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT> 5x upper level of normal (ULN) or total bilirubin > 2x ULN with direct bilirubin > 20% of the total
- •Platelet count < 50 x 10*9/L
- •Hypertension defined as > 95th age percentile
- •Life expectancy < 3 months
- •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
- •Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- •Hypersensitivity or any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
- •Inability to cooperate with the study procedures
- •Previous randomization to this study
- •Participation in a study with an investigational drug or medical device within 30 days prior to randomization
研究组 & 干预措施
Rivaroxaban
Age and body weight-adjusted twice daily dosing of rivaroxaban to achieve a similar exposure as that observed in adults treated for venous thromboembolism (VTE) with 20 mg rivaroxaban once daily
干预措施: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
结局指标
主要结局
Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
时间窗: During or within 2 days after stop of study treatment (up to 32 days)
Major bleeding is defined as overt bleeding and: * associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or * leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or * occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or * contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: * medical intervention, or * unscheduled contact (visit or telephone call) with a physician, or * cessation (temporary) of study treatment, or * discomfort for the child such as pain or * impairment of activities of daily life (such as loss of school days or hospitalization).
次要结局
- Number of Subjects With Symptomatic Recurrent Venous Thromboembolism(From start of the study treatment up to 30-days post study treatment period (approximately 60 days))
- Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging(At the end of the 30-day treatment period)
- Change From Baseline in Prothrombin Time at Specified Time Points(Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose))
- Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points(Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose))
- Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points(Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose))