EUCTR2009-017313-30-AT进行中（未招募）不适用
Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism
适应症
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
- •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
- •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
- •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
- •Change in subject's chronic medication within 14 days prior to study drug
- •administration (Visit 2)
研究者
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