Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
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.
Inclusion Criteria:

 -  Chronological age ≥ 3

 -  Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls

 -  Prepubertal at Visit 1

 -  Height SD score of < -2

 -  IGF-1 SD score of < -2

 Exclusion Criteria:

 -  Prior treatment with GH, IGF-1, or other growth-influencing medications

 -  Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal
 abnormality)

 -  Chronic illness such as diabetes, cystic fibrosis, etc.