A RANDOMISED, CONTROLLED, MULTIDOSE, MULTICENTRE, ADAPTIVE PHASE II/III STUDY IN INFANTS WITH PROLIFERATING INFANTILE HEMANGIOMAS (IHS) REQUIRING SYSTEMIC THERAPY TO COMPARE 4 REGIMENS OF PROPRANOLOL (1 OR 3 MG/KG/DAY FOR 3 OR 6 MONTHS) TO PLACEBO (DOUBLE BLIND).
- Conditions
- D18-D18 Haemangioma and lymphangioma, any siteHaemangioma and lymphangioma, any site
- Registration Number
- PER-115-10
- Lead Sponsor
- Pierre Fabre Dermatologie,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 35
• Written informed consent (s) are obtained for participation in the study and for the use of patient imaging studies, in compliance with national standards, by the parent (s) (s) of the patient or his / her tutor (s) before performing any study procedure.
• The patient has between 35 and 150 days, inclusive, at the time of inclusion and, somewhere in the body except in the diaper area, has a proliferating HI (objective hemangioma) that requires systemic therapy and whose maximum diameter is of at least 1.5 cm.
• The patients health status is unstable from a medical point of view and may affect his chances of completing the study.
• The patient has one or more of the following medical conditions: Congenital hemangioma; Kasabach-Merritt syndrome; bronchial asthma; bronchospasm; hypoglycemia (<40 mg / dl or at risk); untreated pheochromocytoma; hypotension (<50/30 mmHg); second or third degree heart block; Cardiogenic shock; metabolic acidosis; bradycardia (<80 Ipm); severe circulatory abnormalities in the peripheral arteries; Raynaud´s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal angina; PHACES syndrome confirmed with central nervous system involvement.
• The patient previously received at least one of the following prohibited medications: systemic corticosteroids (oral, intravenous or intramuscular), intralesional or topical, imiquimod, vincristine, alpha interferon, propranolol or other beta blockers
• The patient received prior treatment for HI, including any surgical and / or medical procedure (for example, laser therapy)
• The patient´s mother breastfed the patient while receiving treatment with beta blockers (including propranolol) or breastfed the patient during the 15 days prior to random distribution while receiving treatment with systemic corticosteroids (oral, intravenous or intramuscular), vincristine or interferon alfa
• It is known that the patient has hypersensitivity to propranolol and / or some other beta blocker
• The patient had an anaphylactic reaction before
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:It will be evaluated on the basis of qualitative, centralized, independent, blind and intra-patient (type 1) evaluations of the photographs of the S24 target HI, compared to the baseline period.<br>Measure:Evolution of the target HI from baseline to week 24.<br>Timepoints:week 24.<br>
- Secondary Outcome Measures
Name Time Method