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.
- 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
- Prior treatment with GH, IGF-1, or other growth-influencing medications
- Growth failure associated with other identifiable causes (e.g., syndromes,
- Chronic illness such as diabetes, cystic fibrosis, etc.