EUCTR2009-013262-84-IT进行中（未招募）不适用
A randomized, controlled, multidose, multicenter, adaptive, phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind) - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 470
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
- •Written informed consent(s) for study participation and the use of the patient s images are obtained according to national regulations from the patient s parent(s) or guardian(s) prior to performing any study procedures The patient is 35 to 150 days old, inclusive, at inclusion A facial proliferating IH (target hemangioma) with largest diameter of at least 1.5 cm, requiring systemic therapy is present.
- •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
- •The patient has a medically unstable health status that may interfere with his/her ability to complete the study The patient presents with one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycaemia (or at risk); untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; severe peripheral arterial circulatory disturbances; Raynaud s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal s angina; documented PHACES syndrome with central nervous system involvement The patient has received at least one of the following medications contra-indicated in association with propranolol within 15 days of randomisation:Anaesthetic agents (the exclusion period is shortened to 48 hours, if anaesthesia has been performed for diagnosis investigation (e.g. MRI, ), Anti-arrhythmics, Calcium channel blockers, Chlorpromazine, Cimetidine, Clonidine,Digitalis glycosides, Dihydropyridines, Ergotamine, Hydralazine, Hypoglycaemic agents, Lignocaine, Prostaglandin synthetase inhibiting drugs, Sympathomimetic agents and parenteral adrenaline The patient has previously been administered systemic or intralesional corticosteroids, vincristine, alfa-interferon, propranolol or other beta-blockers The patient has previously been administered treatment for IH or surgical procedures have been performed to remove one or more IHs The patient is known to have an allergy to beta-blockers One or more of the following types of IH are present:Life-threatening IH; Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.); Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures Diagnosis of the soft tissue tumour as IH is not clinically certain, particularly in the case of sub-dermal lesions The patient was born prematurely and has not yet reached his/her term equivalent age (e.g. an infant born 2 months prematurely cannot be included before the age of 2 months) LVEF≤40% The patient is participating in another clinical study or the patient lives in the same household as an infant already participating in this or another study.
研究者
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