EUCTR2009-013262-84-LT进行中（未招募）不适用
A randomised, controlled, multidose, multicentre, 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).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
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:
- •- 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 proliferating IH (target hemangioma) requiring systemic therapy is present anywhere on the body except on
- •the diaper area, with largest diameter of at least 1.5 cm.
- •- If required by national regulations, registered with a social security or health insurance system and/or whose
- •parent(s) or legal 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: 450
- •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:
- •- 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 (< 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; documented PHACES
- •syndrome with central nervous system involvement
- •- 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 of randomisation:
- •o Anaesthetic agents, lidocaïne (the exclusion period is shortened to 48 hours, if anaesthesia has been performed
- •for diagnosis investigation e.g. MRI…)
- •o Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents,
- •vasodilators (hydralazine hydrochloride…), clonidine…
- •o Hypoglycaemic agents or drugs able to induce hypoglycaemia
- •o Inducers of hepatic drug metabolism or substrates or inhibitors of CYP2D6, CYP1A2, CYP2C19
- •o Anti-ulcer drugs (cimetidine, ranitidine, proton pomp inhibitors other than omeprazole and lanzoprazole)
- •o Metoclopramide
- •o Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
- •o Sympathomimetic agents and parenteral adrenaline
- •o Benzodiazepines
- •o Neuroleptic drugs (chlorpromazine, sultopride hydrochloride…)
- •o Other drugs: triptans, ergotamine, theophylline, warfarin, thyroxine, floctafenine
- •- The patient has previously been administered at least one of the following prohibited medications: systemic
- •(oral, intra-venous or intra-muscular), intra-lesional or topical corticosteroids, imiquimod, vincristine, alfainterferon,
- •propranolol or other beta-blockers
- •- The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser
- •- The patient’s mother has been breastfeeding the patient while she was also being treated with beta-blockers
- •(including propranolol) or, she has been breastfeeding the patient within 14 days of randomisation while she
- •was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfainterferon
- •- The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
- •- The patient has previously experienced an anaphylactic reaction
- •- One or more of the following types of IH are present:
- •o Life-threatening IH
- •o Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway
- •lesions, etc.)
- •o 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% and/or cardiomyopathy and/or hereditary arrhythmia disorder
- •- The patient is participating in another clinical study or the patient lives in t
研究者
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