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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
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infantile Hemangioma

Intervention: Propranolol (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Pierre Fabre Dermatology

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

Overall contact:
Jean-Jacques VOISARD, MD, Phone: +33 5 63 58 88 00, Email: jean.jacques.voisard@pierre-fabre.com


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

Primary outcome: Complete/nearly complete resolution of the target IH at W24 compared to baseline based on the intra-patient blinded centralised independent qualitative assessments of W24 photographs.

Secondary outcome: -Success/failure based on the investigator qualitative assessment of complete resolution at W48. -Time to first sustained improvement based on centralised qualitative assessments of paired patient-visits

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:

- Facial proliferating IH (target hemangioma) with a diameter of at least 1. 5 cm,

requiring systemic therapy

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

Jean-Jacques VOISARD, MD, Phone: +33 5 63 58 88 00, Email: jean.jacques.voisard@pierre-fabre.com

CHU St.Justine, Montreal H3T 1C5, Canada; Recruiting
Julie Powell, Principal Investigator

The Hospital for Sick Children, Toronto M5G 1H4, Canada; Recruiting
Elena Pope, Principal Investigator

Hôpital Pellegrin-Enfants, Bordeaux 33076, France; Recruiting
Christine Leauté-Labrèze, Principal Investigator

Hopital Claude Huriez, Lille 59037, France; Recruiting
Delphine Staumont-Sallé, Principal Investigator

Hôpital Femme Mère Enfant, Lyon 69677, France; Recruiting
Laurent Guibaud, Principal Investigator

CHU Hôtel Dieu, Nantes 44093, France; Recruiting
Sébastien Barbarot, Principal Investigator

Hôpital Archet 2, Nice 06202, France; Recruiting
Jean-Philippe Lacour, Principal Investigator

Hôpital Armand Trousseau, Paris 75012, France; Recruiting
Arnaud Picard, Principal Investigator

Hôpital Necker Enfants malades, Paris 75015, France; Recruiting
Dominique Hamel-Teillac, Principal Investigator

Hôpital des enfants, Toulouse 31100, France; Recruiting
Juliette Mazereeuw-Hautier, Principal Investigator

Hôpital Clocheville, Tours 37044, France; Recruiting
Gérard Lorette, Principal Investigator

Universitätsklinikum Freiburg, Freiburg D-79106, Germany; Recruiting
Jochen Roessler, Principal Investigator

Kinderkrankenhaus Wilhelmstift, Hamburg D-22149, Germany; Recruiting
Peter Hoeger, Principal Investigator

Universitätsklinikum Schleswig-Holstein, Kiel 24105, Germany; Recruiting
Regina Foelster-Holst, Principal Investigator

Kinderchirurgische Klinik Ludwig-Maximilians-Universität, München D-30337, Germany; Recruiting
Rainer Grantzow, Principal Investigator

University of Bari, Bari 70124, Italy; Not yet recruiting
Ernesto Bonifazi, Principal Investigator

Vascular Unit IRCCS Gaslini, Genova 16147, Italy; Recruiting
Pietro Dalmonte, Principal Investigator

Clinica Dermatologica, Milano 20122, Italy; Recruiting
Carlo Gelmetti, Principal Investigator

Ospedale Pediatrico Bambino Gesu, Roma 00165, Italy; Not yet recruiting
May Chebl El Hachem, Principal Investigator

Hospital Sant Pau de Barcelona, Barcelona 08025, Spain; Recruiting
Eulalia Baselga, Principal Investigator

Hospital San Juan de Dios Barcelona, Esplugues de Llobregat 08950, Spain; Recruiting
Antonia Gonzalez Enseñat, Principal Investigator

Hospital La Paz, Madrid 28056, Spain; Recruiting
Juan Carlos Lopez Gutierrez, Principal Investigator

Hospital Universitario Infantil Niño Jesús, Madrid 28009, Spain; Recruiting
Antonio Torrelo, Principal Investigator

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain; Recruiting
Jose Bernabeu Wittel, Principal Investigator

University of California, Irvine, California 92697-1385, United States; Recruiting
Brandie Metz, Principal Investigator

Lucile Packard Children's Hospital, Redwood City, California 94063-5334, United States; Recruiting
Alfred Lane, Principal Investigator

San Diego Children's Hospital, San Diego, California 92123, United States; Recruiting
Sheila Friedlander, Principal Investigator

Miami Children's Hospital, Miami, Florida 33155, United States; Recruiting
Ana Duarte, Principal Investigator

Emory University, Atlanta, Georgia 30322, United States; Not yet recruiting
Leslie Lawley, Principal Investigator

Children's Memorial Hospital, Chicago, Illinois 60614, United States; Recruiting
Anthony Mancini, Principal Investigator

Children's Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting
Marylin Liang, Principal Investigator

Cardinal Glennon Children's Hospital, St.Louis, Missouri 63104, United States; Not yet recruiting
Elaine Siegfried, Principal Investigator

State University of NY, Brooklyn, New York 11203, United States; Recruiting
Sharon Glick, Principal Investigator

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio 45229, United States; Recruiting
Anne Lucky, Principal Investigator

Oregon Health Sciences University, Portland, Oregon 97239, United States; Recruiting
Dawn Siegel, Principal Investigator

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States; Recruiting
Albert Yan, Principal Investigator

Seattle Children's Hospital, Seattle, Washington 98105, United States; Recruiting
Robert Sidbury, Principal Investigator

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. No abstract available.

Sans V, Dumas de la Roque E, 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 Aug 10; [Epub ahead of print]

Starting date: January 2010
Last updated: August 20, 2010

Page last updated: October 04, 2010

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