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

• Height Velocity Over the Study Period 0 - 34 Weeks [Intent to Treat Population] [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]
  Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
  
  
• Height Velocity Over the Study Period 34 - 86 Weeks [Intent to Treat Population] [ Time Frame: Weeks 34 to 86 ] [ Designated as safety issue: No ]
  Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement.
  
  

• Changes in Height Standard Deviation (SD) Score Over the Study Period 0 - 34 Weeks [Intent to Treat Population] [ Time Frame: Weeks 0 - 34 ] [ Designated as safety issue: No ]
  Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
  
  
• Changes in Height Standard Deviation (SD) Score Over the Study Period 34 - 86 Weeks [ Time Frame: Weeks 34 - 86 ] [ Designated as safety issue: No ]
  Height to be measured standing without shoes as the average of three measurements by the same observer using identical technique with a Harpenden or other wall mounted stadiometer. Reposition subject between each measurement. Please note that Standard Deviation (SD) Score is a term used in growth studies. The SD Score is calculated as the patient value minus the mean divided by the standard deviation. The mean and the standard deviation vary depending on the age and sex of the child.
  
  
• Bone Age - Change From Pretreatment Minus Change in Chronological Age Over the Study Period 0 - 86 Weeks [Intent to Treat Population] [ Time Frame: Weeks 0 - 86 ] [ Designated as safety issue: No ]
  Plain X-rays of the left hand and wrist exposed for bone age appraisal. The films are sent to a central facility for standardized evaluation.
  
  
• Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-1 (IGFBP-1) From Baseline to Week 86 [ Time Frame: 86 weeks ] [ Designated as safety issue: No ]
  Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-1 in the growth factor panel.
  
  
• Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-2 (IGFBP-2) From Baseline to Week 86 [ Time Frame: 86 weeks ] [ Designated as safety issue: No ]
  Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-2 in the growth factor panel.
  
  
• Percent Changes in Serum Concentration of Insulin-like Growth Factor Binding-3 (IGFBP-3) From Baseline to Week 86 [ Time Frame: 86 weeks ] [ Designated as safety issue: No ]
  Blood sample was collected while subject is in a fasting state for measuring the level of IGFBP-3 in the growth factor panel.
  
  
• Percent Changes in Serum Concentration of Acid Labile Subunit (ALS) From Baseline to Week 86 [ Time Frame: 86 weeks ] [ Designated as safety issue: No ]
  Blood sample was collected while subject is in a fasting state for measuring the level of Serum Concentration of Acid Labile Subunit (ALS).
  
  
• 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 ]
  

Drug: rhIGF-1 (mecasermin) for a period of 86 weeks
once a day rhIGF-1 injections

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.