Primary Outcome Measures:
- Increase in height velocity over the study period [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in serum concentration of insulin-like growth factor binding-1 (IGFBP-1, IGFBP-2, IGFBP-3) and acid labile subunit (ALS) [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
- Changes in height standard deviation (SD) score over one year [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
- Changes in bone age over one year [ Time Frame: One year ] [ Designated as safety issue: No ]
- rhIGF-1 doses required to achieve the serum IGF-1 targets with measures taken at each study visit [ Time Frame: 34, 52 and 86 weeks ] [ Designated as safety issue: No ]
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.