NCT00125190

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 Primary IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insulin-Like Growth Factor-1 Deficiency
• Growth Disorders

Interventions

Type	Name	Description
DRUG	rhIGF-1 (mecasermin) for a period of 86 weeks	Once a day rhIGF-1 injections

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2005-07-29
• Last updated: 2020-07-27
• Results posted: 2010-04-15

Locations

1 site across 1 country: United States