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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
6 months
No
Christine Labreze, MD
Study Chair
Hopital de Bordeaux
United States: Food and Drug Administration
V00400 SB 201 Study
NCT01056341
January 2010
December 2013
Name | Location |
---|---|
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Children's Hospital Boston | Boston, Massachusetts 02115 |
Oregon Health Sciences University | Portland, Oregon |
Emory University | Atlanta, Georgia 30322 |
Children's Memorial Hospital | Chicago, Illinois 60614 |
Seattle Children's Hospital | Seattle, Washington 98105 |
University of California | San Francisco, California 94108 |
Rady Children's Hospital | San Diego, California 92123 |
Lucile Packard Children's Hospital | Redwood City, California 94063-5334 |
John Hopkins University School of Medicine | Baltimore, Maryland 21287 |
State University of NY | Brooklyn, New York 11203 |
Dell Children's Medical center | Austin, Texas 78723 |