NCT01056341

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

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).

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 512 (actual)
• Sponsor: Pierre Fabre Dermatology · Industry
• Sex: All
• Age: 35 Days – 150 Days
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Infantile Hemangioma

Interventions

Type	Name	Description
DRUG	Propranolol	Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
DRUG	Placebo	Treatment with placebo for 6 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-05-01
• Completion: 2013-11-01
• First posted: 2010-01-26
• Last updated: 2015-12-10
• Results posted: 2014-06-24

Locations

59 sites across 16 countries: United States, Australia, Canada, Czechia, France, Germany, Hungary, Italy, Lithuania, Mexico, New Zealand, Peru, Poland, Romania, Russia, Spain