NCT02497716已完成1 期
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 47
- 试验地点
- 21
- 主要终点
- AUC (area under the curve)
研究概览
简要总结
To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with an age ≥2 months and weight between 3 and <12 kg, who have completed anticoagulant treatment at least 10 days prior to the planned study drug administration.
- •Gestational age at birth of at least 37 weeks
- •Oral feeding/ nasogastric/ gastric feeding for at least 10 days
- •Normal PT and aPTT within 10 days prior to planned study drug administration
- •Written informed consent provided and, if applicable, child assent provided
排除标准
- •Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
- •Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
- •An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
- •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 > 2x ULN with direct bilirubin > 20% of the total.
- •Platelet count < 50 x 10^9/L
- •Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)
- •Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, e.g., all human immunodeficiency virus protease inhibitors and the following azoleantimycotic agents: ketoconazole, itraconazole, voriconazole, and posaconazole, if used systemically (fluconazole is allowed)
- •Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- •Inability to cooperate with the study procedures
- •Hypersensitivity to rivaroxaban
- •Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
- •History of gastrointestinal disease or surgery associated with impaired absorption
研究组 & 干预措施
Rivaroxaban
Experimental
Single arm, open label study
干预措施: Rivaroxaban (Xarelto, BAY59-7939 (Drug)
结局指标
主要结局
AUC (area under the curve)
时间窗: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Only PK will be tested in central lab
Cmax (maximum observed drug concentration)
时间窗: 4x within 8 hrs post study drug administrationh and 1x between 24-28h after administration
Only PK will be tested in central lab
次要结局
- Prothrombin time (PT)(Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration)
- Activated partial thromboplastin time (aPTT)(Pre-administration, if not done within the past 10 days, and then 24-28 hours after drug administration)
- Composite of major bleeding and clinically relevant non-major bleeding(From dose administration until follow up call on day 8+3)
研究者
研究点 (21)
Loading locations...
相似试验
进行中（未招募）
1 期
Single-dose study testing rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clotEUCTR2015-000962-76-ATBayer AG58
进行中（未招募）
1 期
Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clotThrombosisMedDRA version: 19.1Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2015-000962-76-FIBayer AG58
进行中（未招募）
1 期
Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clotEUCTR2015-000962-76-ITBAYER AG47
进行中（未招募）
1 期
Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clotThrombosisMedDRA version: 20.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2015-000962-76-BEBayer AG47
进行中（未招募）
1 期
Single-dose study testing a rivaroxaban granules to be diluted into an oral suspension in children from 2 months to 12 years with previous blood clotThrombosisMedDRA version: 20.0Level: PTClassification code 10043607Term: ThrombosisSystem Organ Class: 10047065 - Vascular disordersEUCTR2015-000962-76-IEBayer AG58