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

Stopped early · Phase 2

Conditions studied: Noonan Syndrome

In brief

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.

Key facts

Study ID

NCT00351221

Run by

Insmed Incorporated

People needed

24

Last updated by the study team

2007-03-30

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of Noonan syndrome
• Height less than the 3rd percentile for age and sex (height SDS < -1.88)
• Basal IGF-I less than the mean for age and sex (IGF-I SDS < 0)
• Chronological age greater than 2 years
• Bone age ≤ 11 years for boys, and ≤ 10 years for girls
• Pre-pubertal
• Documented pre-treatment height velocity less than the mean for age and sex

You may not qualify if…

• Clinically significant diseases
• Chronic illnesses
• Prior treatment with rhIGF-1

Where it is running

• Schneider Children's Hospital — New Hyde Park, New York, United States
• Columbus Children's Hospital — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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