Growth Disorders Clinical Trial
Official title:
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With Primary IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study
This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.
Growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that
has been used to describe patients with intrinsic cellular defects in growth hormone (GH)
action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations
[SDs] below the mean for age and gender), and abnormal serum IGF-1 (<-2 SDs below the mean
for age and gender).
The trial is an open-label, concentration-controlled trial conducted at up to 20 centers
throughout the United States.
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