A randomised, controlled, multidose, multicentre, adaptive phase II/III study in infants with proliferating infantile hemangiomas requiring systemic therapy to compare four regimens of propranolol (1 or 3 mg/kg/day for 3 or 6 months) to placebo (double blind).

Phase 1

• Conditions: Proliferating Infantile Hemangioma; MedDRA version: 12.0Level: LLTClassification code 10018814Term: Haemangioma

• Registration Number: EUCTR2009-013262-84-FR
• Lead Sponsor: PIERRE FABRE DERMATOLOGIE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-10
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 470

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 facial proliferating IH (target hemangioma) with largest diameter of at least 1.5 cm, requiring systemic therapy is present.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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 (or at risk); untreated phaeochromocytoma; hypotension; second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia; 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 received at least one of the following medications contra-indicated in association with propranolol within 15 days of randomisation:
o Anaesthetic agents (the exclusion period is shortened to 48 hours, if anaesthesia has been performed for diagnosis investigation (e.g. MRI,…)
o Anti-arrhythmics
o Calcium channel blockers
o Chlorpromazine
o Cimetidine
o Clonidine
o Digitalis glycosides
o Dihydropyridines
o Ergotamine
o Hydralazine
o Hypoglycaemic agents
o Lignocaine
o Prostaglandin synthetase inhibiting drugs
o Sympathomimetic agents and parenteral adrenaline
• The patient has previously been administered systemic or intralesional corticosteroids, vincristine, alfa-interferon, propranolol or other beta-blockers
• The patient has previously been administered treatment for IH or surgical procedures have been performed to remove one or more IHs
• The patient is known to have an allergy to beta-blockers
• 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%
• The patient is participating in another clinical study or the patient lives in the same household as an infant already participating in this or another study.

Study & Design

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