Status:
TERMINATED
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
Lead Sponsor:
Insmed Incorporated
Conditions:
Noonan Syndrome
Eligibility:
All Genders
2-16 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Clinically significant diseases
- Chronic illnesses
- Prior treatment with rhIGF-1
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00351221
Last Update
March 30 2007
Active Locations (2)
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1
Schneider Children's Hospital
New Hyde Park, New York, United States
2
Columbus Children's Hospital
Columbus, Ohio, United States, 43205