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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00351221
Recruitment Status : Terminated (Terminated due to a patent legal settlement)
First Posted : July 12, 2006
Last Update Posted : March 30, 2007
Sponsor:
Information provided by:
Insmed Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Noonan Syndrome Drug: rhIGF-1/rhIGFBP-3 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351221


Locations
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United States, New York
Schneider Children's Hospital
New Hyde Park, New York, United States
United States, Ohio
Columbus Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Insmed Incorporated
Investigators
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Study Director: Kenneth Attie, MD Insmed, Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00351221    
Other Study ID Numbers: INMS-110-801
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: March 30, 2007
Last Verified: February 2007
Additional relevant MeSH terms:
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Noonan Syndrome
Syndrome
Disease
Pathologic Processes
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
 Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Connective Tissue Diseases