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NCT00351221 Clinical Trial

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

Noonan Syndrome Clinical Trial

Official title:
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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00351221
Other study ID # INMS-110-801
Secondary ID
Status Terminated
Phase Phase 2
First received July 11, 2006
Last updated March 29, 2007

Study information
Verified date February 2007
Source Insmed Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 2 Years to 16 Years
Eligibility Inclusion Criteria:

1. A diagnosis of Noonan syndrome

2. Height less than the 3rd percentile for age and sex (height SDS < -1.88)

3. Basal IGF-I less than the mean for age and sex (IGF-I SDS < 0)

4. Chronological age greater than 2 years

5. Bone age = 11 years for boys, and = 10 years for girls

6. Pre-pubertal

7. Documented pre-treatment height velocity less than the mean for age and sex

Exclusion Criteria:

1. Clinically significant diseases

2. Chronic illnesses

3. Prior treatment with rhIGF-1

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rhIGF-1/rhIGFBP-3

Locations
Country Name City State
United States Columbus Children's Hospital Columbus Ohio
United States Schneider Children's Hospital New Hyde Park New York

Sponsors (1)
Lead Sponsor Collaborator
Insmed Incorporated

Country where clinical trial is conducted

United States, 

See also
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Completed NCT02486731 - Hormonal Sensitivity in Patients With Noonan and LEOPARD Syndromes
Completed NCT01927861 - Investigating the Long-term Efficacy and Safety of Two Doses of NN-220 (Somatropin) in Short Stature Due to Noonan Syndrome Phase 3
Recruiting NCT04888936 - Clinical, Genetic, and Epidemiologic Study of Children and Adults With RASopathies
Recruiting NCT06331117 - Effect of RAS/MAPK Pathway Hyperactivation on Growth' and Bone' Profile of the RASopathies N/A
Completed NCT00960128 - Observational Prospective Study on Patients Treated With Norditropin® N/A