EUCTR2009-017313-30-IT进行中（未招募）不适用
Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism - ND
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must fulfill all of the following criteria before being included in the treatment period: • Pediatric subjects =6 months and <18 years of age at the time of administration of study drug who have completed treatment of VTE, but are considered to have a risk for recurrence • Pediatric subjects who can take oral medication • Written informed consent (and age appropriate assent) as per local requirements • Clinically stable pediatric subjects who can be treated on an ambulatory basis.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
排除标准
- •Subjects are to be excluded from the study if they display any of the following criteria: • Any condition requiring ongoing anticoagulation • Known bleeding disorder • Any major or clinically relevant bleed during the previous VTE treatment • Abnormal coagulation test results within 7 days prior to study drug administration (Visit 2) • Planned invasive procedures (including removal of central lines) 24 hours before and after single dose • Participation in a therapeutic study with a new investigational drug within 30 days prior to study drug administration (Visit 2) • Severe renal impairment, eg calculated creatinine clearance <30 mL/min for children > 12 years (for Cockcroft-Gault see Section 14.6) (13) • AST, ALT, and GGT >3 x upper limit of normal (ULN), bilirubin >2 x ULN, any active hepatitis, any history of hepatitis B or C • Known bacterial endocarditis • Life expectancy <3 months • Platelet count <150 x 109/L • Hypertension (as defined by >95th percentile for age) (see Section 14.7) (14) • Concomitant use of strong CYP3A4 inhibitors such as HIV protease inhibitors (indinavir, nelfinavir, ritonavir, atazanavir, lopinavir, amprenavir, saquinavir, delavirdine, tipranavir, darunavir, saquinavir), macrolid/ketolid, antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin), antimycotic agents [itraconazole, posaconazole, variconazole, ketoconazole (topical formulations are allowed)], the antidepressant nefazodone • Pregnancy or lactation in menstruating girls • Previous assignment to treatment during this study • Close affiliation with the investigational site, eg a close relative of the investigator, dependent person (eg employee or student of the investigational site) • Medical disorder, condition, or history of such that would impair the subject`s ability to participate or complete this study in the opinion of the investigator or the sponsor • History of gastrointestinal disease (eg Crohn`s disease) which could result in impaired absorption of the study drug • Any other disease or condition which may influence the physiological metabolic turnover (eg endocrine diseases, febrile condition, severe infections) • Febrile illness within 7 days prior to study drug administration (Visit 2) • History of severe allergies, non-allergic drug reactions, or multiple drug allergies • Hypersensitivity to the investigational drug and/or to inactive constituents • Concomitant use of drugs that influence the coagulation system, eg antiplatelet drugs (such as acetylsalicylic acid, ticlopidine, and clopidogrel, abciximab, tirofiban, and integrelin) or other anticoagulants (anti-thrombins, unfractionated heparin, low molecular weight heparin, hirudin, coumarin-type anticoagulants such as phenprocoumon and warfarin) within 10 days prior to study drug administration (Visit 2) • Concomitant use of strong cytochrome P450 3A4 inducers, eg rifampicin, rifabutin dexamethasone, phenobarbital, primidone, phenytoin, carbamazepine, St. John`s wort (Hypericum perforatum) within 14 days prior to study drug administration (Visit 2) • Change in subject`s chronic medication within 14 days prior to study drug administration (Visit 2)
研究者
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已完成
1 期
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