Single-dose study testing a rivaroxaban granules for oral suspension formulation in children from 2 months to 12 years with previous thrombosis - Phase 1 granules for oral suspension

Bayer AG0 个研究点目标入组 58 人开始时间: 2015年7月9日最近更新: 2018年6月5日

适应症

试验速览

暂无简介。

•1. For group A and B:
•Children with an age between 6 months and <12 years who have completed
•anticoagulant treatment at least 10 days prior to the planned study drug
•administration
•For Group C:
•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 29
•For Groups A, B and C:
•2. Normal PT and aPTT within 10 days prior to planned study drug administration
•3. Written informed consent provided and, if applicable, child assent provided
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 58
•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

•For Groups A, B and C:
•1. Active bleeding or high risk for bleeding, contraindicating anticoagulant therapy
•2. Planned invasive procedures, including removal of central lines, within 24 hours before and after single dose intake
•3. An estimate glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
•4. Hepatic disease which is associated either with:
•? 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.
•5. Platelet count < 50 x 109/L
•6. Hypertension (defined as systolic and/or diastolic blood pressure >95th percentile for age)
•7. 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)
•8. Concomitant use of strong inducers of CYP3A4, e.g., rifampicin, rifabutin,
•phenobarbital, phenytoin and carbamazepine
•9. Inability to cooperate with the study procedures
•10. Hypersensitivity to rivaroxaban
•11. Participation in a study with an investigational drug other than rivaroxaban or a medical device within 30 days prior to treatment
•For Group C only:
•12. History of gastrointestinal disease or surgery associated with impaired absorption

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