28
Participants
Start Date
August 16, 2012
Primary Completion Date
May 24, 2022
Study Completion Date
May 24, 2022
Hydroxyurea
Hydroxyurea solution 100 mg/ml with a starting dose of 20 mg/kg/day by mouth once daily and escalation by 5 mg/kg/day every 8 weeks until hematological toxicity, an Absolute Neutrophil Count of 2000 to 4000/ul, or a maximum dose of 35 mg/kg/day.
Placebo
Sucrose solution 0.2 ml/kg/day by mouth once a day with blinded dose escalation of 0.05 ml/kg/day to match the frequency of dose escalation in the hydroxyurea arm.
Children's Hospital of Philadelphia, Philadelphia
Johns Hopkins Hospital, Baltimore
University of Alabama, Birmingham
St. Louis Children's Hospital, St Louis
Mercy Children's Hospital, Kansas City
National Center for Research Resources (NCRR)
NIH
Washington University School of Medicine
OTHER
Vanderbilt University School of Medicine
OTHER
University of Alabama at Birmingham
OTHER
Children's Hospital of Philadelphia
OTHER
Medical University of South Carolina
OTHER
RTI International
OTHER
Columbia University
OTHER
Children's Mercy Hospital Kansas City
OTHER
Sinai Hospital of Baltimore
OTHER
Johns Hopkins University
OTHER