Conditions: Insulin-Like Growth Factor-1 Deficiency Growth Disorders
Keywords: Primary IGF-1 Deficiency IGF-1
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 45
Healthy volunteers: no

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.

Arms:
arm 1: Subjects received subcutaneous injection (SC) injections of rhIGF-1 once a day.

Interventions: intervention 1: rhIGF-1 (mecasermin) for a period of 86 weeks
Intervention descriptions: intervention 1: Once a day rhIGF-1 injections

Protocol document: