NCT00351221

Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome

A Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 2 Years – 16 Years
• Healthy volunteers: —

Summary

The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) - insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.

Conditions

• Noonan Syndrome

Interventions

Type	Name	Description
DRUG	rhIGF-1/rhIGFBP-3

Timeline

• First posted: 2006-07-12
• Last updated: 2007-03-30

Locations

2 sites across 1 country: United States