Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Noonan Syndrome | Drug: rhIGF-1/rhIGFBP-3 | Phase 2 |
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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Ages Eligible for Study: | 2 Years to 16 Years (Child) |
Sexes Eligible for Study: | All |
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

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
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 |
Study Director: | Kenneth Attie, MD | Insmed, Inc. |
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 |
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 |