Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solutionin Infants With Proliferating Infantile Hemangiomas Requiring SystemicTherapy.

• Conditions: Proliferating Infantile Hemangioma; MedDRA version: 14.1Level: PTClassification code 10018814Term: HaemangiomaSystem 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-LT
• Lead Sponsor: PIERRE FABRE DERMATOLOGIE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-18
• Last Update Posted: 2 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

Exclusion Criteria

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
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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified