- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00351221
Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
March 29, 2007 updated by: Insmed Incorporated
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
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.
Study Overview
Study Type
Interventional
Enrollment
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New Hyde Park, New York, United States
- Schneider Children's Hospital
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Ohio
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Columbus, Ohio, United States, 43205
- Columbus Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 16 years (CHILD)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- Clinically significant diseases
- Chronic illnesses
- Prior treatment with rhIGF-1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kenneth Attie, MD, Insmed, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
July 11, 2006
First Submitted That Met QC Criteria
July 11, 2006
First Posted (ESTIMATE)
July 12, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
March 30, 2007
Last Update Submitted That Met QC Criteria
March 29, 2007
Last Verified
February 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INMS-110-801
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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