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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00351221 |
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Date of registration:
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11/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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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Date of first enrolment:
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May 2006 |
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Target sample size:
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24 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00351221 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Kenneth Attie, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Insmed, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
2 Years
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Noonan Syndrome
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Intervention(s)
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Drug: rhIGF-1/rhIGFBP-3
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Secondary ID(s)
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INMS-110-801
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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