Completed
PHASE2, PHASE3
INTERVENTIONAL
NCT00125190
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Detailed Description
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.
Interventions
Name:
rhIGF-1 (mecasermin) for a period of 86 weeks
Type:
DRUG
Description:
Once a day rhIGF-1 injections
Primary Outcomes
Measure:
Height Velocity From Pretreatment (Week 0) to Week 34
TimeFrame:
Pretreatment to Week 34
Description:
Height was 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. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 34 heights were imputed using the last height SD score carried forward.
Measure:
Height Velocity From Week 34 to 86
TimeFrame:
Week 34 to 86
Description:
Height was 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. The subject was repositioned between each measurement. Height velocity during an interval of time is defined as the change in height during the time interval divided by the duration of the time interval. Missing Week 86 heights were imputed using the last height SD score carried forward.
Trial Information
NCT ID
NCT00125190
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2, PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025