10
Participants
Start Date
July 31, 2004
Primary Completion Date
December 31, 2009
Study Completion Date
January 31, 2010
Oxandrolone
Subjects will be started on a dose of oxandrolone 0.04 mg/kg/day orally, once/day. After 16 weeks, patients will be assessed for hematologic improvement. If this criteria is not met after 16 weeks, the dose will be escalated to 0.08 mg/kg/day. If no improvement is noted after 16 weeks on the escalated dose, oxandrolone therapy will be discontinued.
Cincinnati Children's Hospital Medical Center, Cincinnati
FDA Office of Orphan Products Development
FED
Children's Hospital Medical Center, Cincinnati
OTHER