NCT00368173

IGF-I/IGFBP-3 Therapy in Children and Adolescents With Growth Hormone Insenitivity Syndrome (GHIS) Such as Laron Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: —

Summary

STUDY OBJECTIVE To evaluate the safety, tolerability, and efficacy, as growth velocity (statural growth), of rhIGF-I/rhIGFBP-3 administered for 12 months in pre-pubertal children and adolescents with GHIS. STUDY DESIGN This study is an open-label, multi-center clinical trial to evaluate the safety and effectiveness of rhIGF-I/rhIGFBP-3 to increase rate of growth when administered once daily for 12 months in children and adolescents with growth hormone insensitivity syndrome (GHIS) such as Laron Syndrome. At the end of the initial twelve-month treatment period, additional safety and long-term efficacy data will be assessed in a second 12 month treatment period.

Conditions

• Growth Hormone Insensitivity Syndrome (GHIS)
• Laron Syndrome

Interventions

Type	Name	Description
DRUG	rhIGF-I/rhIGFBP-3

Timeline

• First posted: 2006-08-24
• Last updated: 2012-09-13

Locations

15 sites across 14 countries: United States, Argentina, Australia, Brazil, China, Egypt, Germany, Israel, Italy, Norway, Peru, Slovakia, Turkey (Türkiye), United Kingdom