2025-523109-14-00招募中3 期
A prospective, open-label, non-randomized, multicentre trial to assess the safety and PD of Cangrelor as procedural platelet inhibitor in paediatric subjects from birth to <18 years of age undergoing diagnostic and/or therapeutic percutaneous vascular procedures for management of congenital heart disease
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 7
研究概览
简要总结
To evaluate the safety profile of the recommended dosing regimen of Cangrelor in the paediatric population.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Males and females aged from birth to less than 18 years
- •Diagnosis of CHD, including, but not limited to, patent ductus arteriosus, coarctation of aorta, atrial septal defect, ventricular septal defects, valvular stenosis
- •Expected to undergo a diagnostic and/or therapeutic percutaneous vascular procedure
- •Female subjects fulfilling one of the following criteria: • Women of non-childbearing potential (WONCBP), defined as physiologically incapable of becoming pregnant; • Women of childbearing potential (WOCBP) fulfilling one of the following criteria: o Sexually active: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the end of the follow-up period (Day 4/discharge) o Non-sexually active (contraception is not required in this case)
- •Male subjects fulfilling one of the following criteria: • Non-fertile male subjects (contraception is not required in this case); • Fertile male subjects without a female partner (contraception is not required in this case); • Fertile male subjects with any WOCBP partner: they must be willing to use male condom from the signature of the informed consent and until the end of the follow-up period (Day 4/discharge); • Fertile male subjects with WONCBP partner (contraception is not required in this case).
排除标准
- •Corrected age of <37 weeks at screening
- •History of intracerebral bleeding or cerebral arteriovenous malformation; or evidence of any prior bleeding with neurological deficit
- •Gastrointestinal or genitourinary bleeding within the last 2 weeks prior to screening, excluding normal menstrual cycles
- •Platelet count less than 150,000 cells/µL or higher than 450,000 cells/µL at screening
- •Known allergy to Cangrelor or known sensitivity to any component of Cangrelor
研究组 & 干预措施
Kengrexal 50 mg powder for concentrate for solution for injection/infusion
Test
干预措施: Kengrexal 50 mg powder for concentrate for solution for injection/infusion (Drug)
研究者
Clinical Project Manager
Scientific
Chiesi Farmaceutici S.p.A.
研究点 (7)
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