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

Information source: Pierre Fabre Dermatology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infantile Hemangioma

Intervention: Propranolol (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Pierre Fabre Dermatology

Official(s) and/or principal investigator(s):
Christine Labreze, MD, Study Chair, Affiliation: Hopital de Bordeaux


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.

Clinical Details

Official title: 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).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Interim Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at Week 24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of Week 24 Photographs.

Primary Analysis : Complete/Nearly Complete Resolution of the Target Infantile Hemangioma at W24 Compared to Baseline Based on the Intra-patient Blinded Centralized Independent Qualitative Assessments of W24 Photographs.

Secondary outcome: Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.

Detailed description: Primary objective The primary objective of this study is to identify the appropriate dose and duration of propranolol treatment and demonstrate its superiority over placebo based on the complete/nearly complete resolution of target IH at W24.


Minimum age: 35 Days. Maximum age: 150 Days. Gender(s): Both.


Inclusion Criteria:

- 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 Exclusion Criteria:

- 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


- 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

Locations and Contacts

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 H3T 1C5, Canada

The Hospital for Sick Children, Toronto M5G 1H4, Canada

Children Dermatology, Brno, Czech Republic

Clinic of Dermatovenerology, University, Prague, Czech Republic

Hôpital Pellegrin-Enfants, Bordeaux 33076, France

Hôpital Femme Mère Enfant, Lyon 69677, France

CHU Hôtel Dieu, Nantes 44093, France

Hôpital Archet 2, Nice 06202, France

Hopital Robert Debre - Consultation de Dermatologie, Paris 75019, France

Hôpital Armand Trousseau, Paris 75012, France

Hôpital Necker Enfants malades, Paris 75015, France

Hopital Nord-CHU St Etienne, St-Etienne 42055, France

Hôpital des enfants, Toulouse 31100, France

Hôpital Clocheville, Tours 37044, France

Universitätsklinikum Freiburg, Freiburg D-79106, Germany

Kinderkrankenhaus Wilhelmstift, Hamburg D-22149, Germany

Universitätsklinikum Schleswig-Holstein, Kiel 24105, Germany

Kinderchirurgische Klinik Ludwig-Maximilians-Universität, München D-30337, Germany

Heim Pál Gyermekkórház,, Budapest, Hungary

University of Bari, Bari 70124, Italy

Clinica Dermatologica, Milano 20122, Italy

Vilnius University Children's Hospital, Vilnius, Lithuania

Hospital Infantil de Mexico Federico Gomez, Mexico CIty, Mexico

Auckland Dermatology, Auckland, New Zealand

Waikato Clinical Research 2008 Ltd., Hamilton, New Zealand

Clinica Internacional, Lima, Peru

Hospital Nacional Edgardo Rebagliati Martins, Lima, Peru

Instituto Nacional de Salud del Niño, Lima, Peru

Klinika Chirurgii i Urologii Dzieci i Mlodziezy Akademii Medycznej, Gdansk, Poland

University Children's Hospital, Krakow, Poland

Department of Pediatric Surgery and Oncology, Lodz, Poland

Klinika Onkologii, Centrum Zdrowia Dziecka, Warszawa, Poland

I.O.M.C Alfred Rusescu, Bucharest 020395, Romania

Spitalul Clinic Urgenta pentru Copii Grigore Alexandrescu, Bucharest 011743, Romania

Spitalul de Copii Dr. Victor Gomoiu, Bucharest 022102, Romania

Spitalul Clinic de Urgenta pentu Copii Sf. Maria, Iasi 700309, Romania

Spitalul de Urgenta Copii, Louis Turcanu, Timisoara 300011, Romania

Medical University - Filatov Pediatric Hospital, Moscow, Russian Federation

Medical Pediatric Academy, St-Peterburg, Russian Federation

Neonatal Intensive Care Department, St-Peterburg, Russian Federation

Servicio de Dermatologia del Hospital Infantil, A Coruna 15006, Spain

Hospital Sant Pau de Barcelona, Barcelona 08025, Spain

Hospital La Paz, Madrid 28056, Spain

Hospital Universitario Infantil Niño Jesús, Madrid 28009, Spain

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain

Hospital Universitario de Valencia, Valencia 15006, Spain

University of California, Irvine, California 92697-1385, United States

Lucile Packard Children's Hospital, Redwood City, California 94063-5334, United States

Rady Children's Hospital, San Diego, California 92123, United States

Miami Children's Hospital, Miami, Florida 33155, United States

Children's Memorial Hospital, Chicago, Illinois 60614, United States

Cardinal Glennon Children's Hospital, St.Louis, Missouri 63104, United States

State University of NY, Brooklyn, New York 11203, United States

Oregon Health Sciences University, Portland, Oregon 97239, United States

Dell Children's Medical center, Austin, Texas 78723, United States

Seattle Children's Hospital, Seattle, Washington 98105, United States

Additional Information

Related publications:

Léauté-Labrèze C, Dumas de la Roque E, Hubiche T, Boralevi F, Thambo JB, Taïeb A. Propranolol for severe hemangiomas of infancy. N Engl J Med. 2008 Jun 12;358(24):2649-51. doi: 10.1056/NEJMc0708819.

Sans V, de la Roque ED, Berge J, Grenier N, Boralevi F, Mazereeuw-Hautier J, Lipsker D, Dupuis E, Ezzedine K, Vergnes P, Taïeb A, Léauté-Labrèze C. Propranolol for severe infantile hemangiomas: follow-up report. Pediatrics. 2009 Sep;124(3):e423-31. doi: 10.1542/peds.2008-3458. Epub 2009 Aug 10.

Starting date: January 2010
Last updated: May 21, 2014

Page last updated: August 23, 2015

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