Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Infantile Hemangioma

In brief

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

Key facts

Study ID

NCT01056341

Run by

Pierre Fabre Dermatology

People needed

512

Starts

2010-01-01

Expected to finish

2013-11-01

Last updated by the study team

2015-12-10

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Proliferating IH (target hemangioma) requiring systemic therapy anywhere on the body except on the diaper area with largest diameter of at least 1.5 cm

You may not qualify if…

• 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 has previously been treated for IH, including any surgical and/or medical procedures (e.g. laser therapy)
• The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers
• One or more of the following types of IH are present:
• Life-threatening IH
• Function-threatening IH (e.g. those causing impairment of vision, respiratory compromise caused by airway lesions, etc.)
• Ulcerated IH (whatever the localisation) with pain and lack of response to simple wound care measures
• 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 systolic function) ≤40% and/or cardiomyopathy and/or hereditary arrhythmia disorder

Where it is running

• Lucile Packard Children's Hospital — Redwood City, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Miami Children's Hospital — Miami, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
• State University of NY — Brooklyn, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Dell Children's Medical center — Austin, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Eastern Clinical Research Unit - Box Hill Hospital — Box Hill, Australia
• Royal Children's Hospital — Melbourne, Australia
• Sydney Children's Hospital — Randwick, Australia
• CHU St.Justine — Montreal, Canada
• The Hospital for Sick Children — Toronto, Canada
• Children Dermatology — Brno, Czechia
• Clinic of Dermatovenerology, University — Prague, Czechia
• Hôpital Pellegrin-Enfants — Bordeaux, France
• Hôpital Femme Mère Enfant — Lyon, France
• CHU Hôtel Dieu — Nantes, France
• Hôpital Archet 2 — Nice, France
• Hôpital Armand Trousseau — Paris, France
• Hôpital Necker Enfants malades — Paris, France
• Hopital Robert Debre - Consultation de Dermatologie — Paris, France
• Hopital Nord-CHU St Etienne — Saint-Etienne, France
• University of California — Irvine, California, United States

Full record on ClinicalTrials.gov

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