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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
512
Propranolol (1 or 3 mg/kg/day for 3 or 6 months)
Treatment with placebo for 6 months
University of California
Irvine, California, United States
Lucile Packard Children's Hospital
Redwood City, California, United States
Rady Children's Hospital
San Diego, California, United States
Miami Children's Hospital
Miami, Florida, United States
Children's Memorial Hospital
Chicago, Illinois, United States
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.
Time frame: 6 months
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.
Time frame: 6 months
Success/Failure Based on the Investigator Qualitative Assessment of Complete Resolution at W48.
Time to first sustained improvement based on centralized qualitative assessments of paired patient-visits
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
State University of NY
Brooklyn, New York, United States
Oregon Health Sciences University
Portland, Oregon, United States
Dell Children's Medical center
Austin, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
...and 49 more locations