EUCTR2011-005155-14-HU进行中（未招募）不适用
An open-label, pharmacokinetic, pharmacodynamic, and tolerability study of AVE5026 administered at weight-adjusted doses to patients under 18 years of age with a Central Venous Line (CVL)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 44
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
- •Male and female patient - age between = 38 gestational weeks and < 18 years
- •Central Venous Line implanted for an expected duration = 6 days from study enrolment
- •Patient hospitalized or able to receive daily injection for at least 6 days and provide plasma samples at Day 4, 5 and 6 at the pre-specified time points
- •Written informed consent signed by legal representative(s) in accordance with local regulation, and possibly assent form by the child (country/age specific)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •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
- •Patient for whom anticoagulant therapy is contraindicated
- •Planned treatment with other antithrombotic agents within 2 weeks prior to enrolment and during the course of the study
- •Any previous exposure to AVE5026 (eg. previous enrolment in the current study)
- •Documented history of heparin-induced thrombocytopenia
- •Severe thrombocytopenia (platelets < 50 x 10 000 000 000/L)
- •Active bleeding
- •Recent (less than 3 weeks prior to enrollment) brain, spinal or ophthalmologic surgery
- •Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure greater than 2 standard deviations above the age-related norm
- •Severe hepatic disease (e.i. more than 2.5 times the upper limit for age of hepatic enzymes)
- •Severe renal insufficiency (estimated creatinine clearance < 30 ml/min using the Schwartz formula)
- •Any condition that, in the opinion of the Investigator, would expose the patient to an unfavorable risk/benefit ratio
- •Presence or history of drug hypersensitivity
- •Any patient currently involved in another clinical trial with an investigational drug according to applicable regulations
- •Any patient or parent(s)/legal guardian(s) who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development
- •Any patient or parent(s)/legal guardian(s) who cannot be contacted in case of emergency
- •Pregnant or breast-feeding female
- •Female of childbearing potential who are unwilling to abstain from sexual intercourse and therefore are at risk of becoming pregnant and are not protected by highly effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy
研究者
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