Growth Hormone Insensitivity Syndrome (GHIS) Clinical Trial
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.
n/a