A multicentre, open-label, repeated-dose, pharmacokinetic study of Propranolol in infants treated for proliferating infantile hemangiomas (IHs) requiring systemic therapy.
- Conditions
- Proliferating Infantile HemangiomaMedDRA version: 12.1 Level: LLT Classification code 10018814 Term: Haemangioma
- Registration Number
- EUCTR2009-018102-22-FR
- Lead Sponsor
- PIERRE FABRE DERMATOLOGIE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 23
A patient will be eligible if he/she meets all of the following criteria:
• Written informed consent(s) for study participation is 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,
• Proliferating IH (target hemangioma) requiring systemic therapy is present: function-threatening IH, IH in certain anatomic locations that often leave permanent scars or deformity, large facial IH, smaller IH in exposed areas, severe ulcerated IH, pedunculated IH,
• Affiliated with, or beneficiary of the social security.
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
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); 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 15 days of randomisation:
o Anaesthetic agents (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 Anti-ulcer drugs (cimetidine…)
o Metoclopramide
o Prostaglandin synthetase inhibitors
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 (and/or the mother if she is breastfeeding the patient) has received any treatment which could lead to induction or inhibition of hepatic microsomal enzymes within 2 months of randomisation,
• 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, alfa-interferon, Propranolol or other beta-blockers,
• The patient has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy),
• 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 15 days of randomisation while she was also being treated with systemic (oral, intra-venous or intra-muscular) corticosteroids, vincristine or alfa-interferon,
• The patient is known to have a hypersensitivity to Propranolol or to any component of the investigational product and/or any other beta-blockers,
• The patient has previously experienced an anaphylactic reaction,
• The patient has a life-threatening IH,
• 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 (left ventricular
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method