Study Stopped
Terminated due to a patent legal settlement
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
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
1 other identifier
interventional
24
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2006
CompletedFirst Posted
Study publicly available on registry
July 12, 2006
CompletedMarch 30, 2007
February 1, 2007
July 11, 2006
March 29, 2007
Conditions
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Schneider Children's Hospital
New Hyde Park, New York, United States
Columbus Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenneth Attie, MD
Insmed, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 11, 2006
First Posted
July 12, 2006
Last Updated
March 30, 2007
Record last verified: 2007-02