Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy.
- Conditions
- Proliferating Infantile HemangiomaMedDRA version: 20.0 Level: PT Classification code 10018814 Term: Haemangioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2009-013262-84-RO
- Lead Sponsor
- PIERRE FABRE DERMATOLOGIE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 456
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
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, 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 14 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 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 c
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