EUCTR2010-023488-16-FR进行中（未招募）1 期
A multicentre, open-label study of propranolol in infants with proliferating infantile hemangioma requiring systemic therapy
PIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE0 个研究点目标入组 70 人开始时间: 2010年12月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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
- •A patient will be eligible if he/she meets all of the following criteria:
- •Patient having been treated and having completed the end of study visit of the study V00400 SB 102 or the study V00400 SB 201 within the previous 6 months
- •Written informed consent(s) for study participation are obtained according to National regulations from the patient’s parent(s) or guardian(s) prior to performing any study procedures
- •Proliferating IH requiring systemic therapy with propranolol in the investigator’s opinion.
- •If required by national regulation, registered with a social security or health insurance system and/or whose parent(s) or guardian(s) is(are) registered with a social security or health insurance system
- •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
- •A patient will be ineligible if he/she meets any of the following criteria:
- •Any patient for whom the medical status has changed since the inclusion in the previous studies, V00400 SB 102 or V00400 SB 201, to a medically unstable health status that may interfere with his/her ability to complete the study
- •Patient in whom any event observed in the previous study would, in the investigator’s opinion, preclude the use of propranolol
- •The patient presents one or more of the following medical conditions:
- •bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina; cardiomyopathy; arrhythmia disorder.
- •The patient (and/or the mother if she is breastfeeding the patient) has received at least one of the following prohibited medications within 14 days before study treatment administration:
- •- Anesthetic agents, lidocaine
- •- Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
- •- Hypoglycaemic agents or drugs able to induce hypoglycaemia
- •- Inducers of hepatic drug metabolism or substrates or inhibitors of CYP2D6, CYP1A2,CYP2C19
- •- Anti-ulcer drugs (cimetidine, ranitidine, proton pomp inhibitors other than omeprazole and lanzoprazole)
- •- Metoclopramide
- •- Sympathomimetic agents and parenteral adrenaline
- •- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
- •- Benzodiazepines
- •- Neuroleptic drugs (chlorpromazine, sultopride hydrochloride…)
- •- Other drugs: triptans, ergotamine, theophylline, warfarin, thyroxine, floctafenine
- •The patient (and/or the mother if she is breastfeeding the patient) is treated with beta-blockers (including propranolol)
- •The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers and/or any ingredient of the test product
- •The patient has previously experienced an anaphylactic reaction
- •Diagnosis of the soft tissue tumour as IH is not clinically certain, particularly in the case of sub-dermal lesions
- •The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
- •Parent(s) or guardian(s) cannot be contacted by telephone in case of emergency
研究者
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