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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).


Phase 2/Phase 3
35 Days
150 Days
Open (Enrolling)
Both
Infantile Hemangioma

Thank you

Trial Information

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).


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.


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
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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Christine Labreze, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital de Bordeaux

Authority:

United States: Food and Drug Administration

Study ID:

V00400 SB 201 Study

NCT ID:

NCT01056341

Start Date:

January 2010

Completion Date:

December 2013

Related Keywords:

  • Infantile Hemangioma
  • Infantile Hemangioma
  • Propranolol
  • Hemangioma
  • Hemangioma, Capillary

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Miami Children's HospitalMiami, Florida  33155-4069
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Children's Hospital BostonBoston, Massachusetts  02115
Oregon Health Sciences UniversityPortland, Oregon  
Emory UniversityAtlanta, Georgia  30322
Children's Memorial HospitalChicago, Illinois  60614
Seattle Children's HospitalSeattle, Washington  98105
University of CaliforniaSan Francisco, California  94108
Rady Children's HospitalSan Diego, California  92123
Lucile Packard Children's HospitalRedwood City, California  94063-5334
John Hopkins University School of MedicineBaltimore, Maryland  21287
State University of NYBrooklyn, New York  11203
Dell Children's Medical centerAustin, Texas  78723