PER-115-10已完成未知
A RANDOMISED, CONTROLLED, MULTIDOSE, MULTICENTRE, ADAPTIVE PHASE II/III STUDY IN INFANTS WITH PROLIFERATING INFANTILE HEMANGIOMAS (IHS) REQUIRING SYSTEMIC THERAPY TO COMPARE 4 REGIMENS OF PROPRANOLOL (1 OR 3 MG/KG/DAY FOR 3 OR 6 MONTHS) TO PLACEBO (DOUBLE BLIND).
Pierre Fabre Dermatologie,0 个研究点目标入组 35 人开始时间: 2011年4月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Written informed consent (s) are obtained for participation in the study and for the use of patient imaging studies, in compliance with national standards, by the parent (s) (s) of the patient or his / her tutor (s) before performing any study procedure.
- •The patient has between 35 and 150 days, inclusive, at the time of inclusion and, somewhere in the body except in the diaper area, has a proliferating HI (objective hemangioma) that requires systemic therapy and whose maximum diameter is of at least 1.5 cm.
排除标准
- •The patients health status is unstable from a medical point of view and may affect his chances of completing the study.
- •The patient has one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycemia (<40 mg / dl or at risk); untreated pheochromocytoma; hypotension (<50/30 mmHg); second or third degree heart block; Cardiogenic shock; metabolic acidosis; bradycardia (<80 Ipm); severe circulatory abnormalities in the peripheral arteries; Raynaud´s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal angina; PHACES syndrome confirmed with central nervous system involvement.
- •The patient previously received at least one of the following prohibited medications: systemic corticosteroids (oral, intravenous or intramuscular), intralesional or topical, imiquimod, vincristine, alpha interferon, propranolol or other beta blockers
- •The patient received prior treatment for HI, including any surgical and / or medical procedure (for example, laser therapy)
- •The patient´s mother breastfed the patient while receiving treatment with beta blockers (including propranolol) or breastfed the patient during the 15 days prior to random distribution while receiving treatment with systemic corticosteroids (oral, intravenous or intramuscular), vincristine or interferon alfa
- •It is known that the patient has hypersensitivity to propranolol and / or some other beta blocker
- •The patient had an anaphylactic reaction before
研究者
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