EUCTR2014-005555-80-ES进行中（未招募）1 期
Efficacy and safety of Hemangiol solution in the treatment of high risk infantile hemangioma. A Multinational Single Arm Study
Pierre Fabre Dermatologie represented by IRPF0 个研究点目标入组 45 人开始时间: 2015年4月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •1. Age 35-150 days old inclusive, also subject born prematurely but of his/her term equivalent age at inclusion (corrected age)
- •2. High risk IH in proliferative phase (target hemangioma):
- •- life-threatening IH
- •- peri-orbital, nasal, labial, laryngo-tracheal, limb joints IHs with functional impact or at risk of functional impact
- •- disfiguring IH (IH > 5cm, glabella location, nasal location, philtrum location, central chin location, central cheek location, labial IH with mouth deformities)
- •- ulcerated IH not responding to simple wound care measures, located anywhere on the body
- •3. If required by national regulations, registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) was (were) registered with a social security or health insurance system
- •4. Written informed consent(s) for study participation and the use of the subject?s images obtained according to national regulations from the subject?s parent(s) or guardian(s) prior to performing any study procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 45
- •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
- •5. Medically unstable health status that may interfere with his/her ability to complete the study, especially acute broncho-pulmonary abnormality
- •6. Presence of one or more of the following medical conditions:
- •- Congenital hemangioma
- •- Kasabach-Merritt syndrome
- •- PHACE syndrome
- •- Hepatic hemangioma
- •- History of bronchospasm
- •- At risk of hypoglycaemia according to the medical file of the subject
- •- Phaeochromocytoma
- •- Hypotension (SBP/DBP <65/45 mmHg for age 35-90 days, < 70/50 mmHg for age 91-150 days)
- •- Second or third degree heart block
- •- Cardiogenic shock
- •- Bradycardia (HR < 100 bpm for age 35-90 days, < 90 bpm for age 91-150 days)
- •- Severe peripheral arterial circulatory disturbances, Raynaud?s phenomenon
- •- Disease of the sinus node (including sinoatrial block)
- •- Uncontrolled heart failure
- •- Prinzmetal?s angina
- •- Hepatic and/or renal impairment
- •- Psoriasis
- •7. Kaliemia > 5.0 mmol/L (only measured for subjects presenting an IH with ulcerated area >= 3 cm)
- •8. Subject?s target hemangioma treated by LASER therapy within the past month,
- •9. The subject (and/or the mother if she is breastfeeding the subject) has received at least one of the following prohibited medications within 14 days before first study drug administration:
- •- Corticosteroids by systemic (oral, intra-venous or intra-muscular), intra-lesional or topical route
- •- Imiquimod
- •- Vincristine
- •- Alfa-interferon
- •- Propranolol or other beta-blockers
- •- Cardiovascular treatments:
- •. bradycardia-inducing calcium channel blockers (diltiazem, verapamil, bepridil),
- •. anti-arrhythmics (propafenone, quinidine, amiodarone, lidocaine),
- •. inotropic agents (digitalis glycosides),
- •. dihydropyridines (amlodipine, felodipine, isradipine, lacidipine, lercanidipine, manidipine, nicardipine, nifedipine, nitrendipine, etc?),
- •. antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc?)
- •- Drugs inducing orthostatic hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen, etc?)
- •- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
- •- Enzyme inducers (rifampicin, phenobarbital,?)
- •- Hypoglycaemic agents or drugs able to induce hypoglycaemia
- •- Lipid lowering agents (cholestyramine, colestipol)
- •- Halogenated anesthetic agents, lidocaine (exclusion period shortened to 48 hours if anaesthesia has been performed for diagnosis investigation, e.g. MRI?)
- •10. Hypersensitivity to any study drug ingredient
- •11. Hypersensitivity any beta-blocker
- •12. Medical history of anaphylactic reaction
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