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Brisbane, California 94005


Purpose:

IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in response to another hormone called growth hormone. Growth Hormone is produced by a small gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors to growth during infancy, childhood, and adolescence. Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a type of growth hormone insensitivity and an inability to grow normally. This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will help children with IGFD grow taller more quickly than children treated with rhGH alone. The study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration (FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH in children with IGF-1 deficiency (IGFD) is investigational.


Criteria:

Inclusion Criteria: - Parents or legally authorized representatives must give signed informed consent before any trial-related activities - IGF-1 SDS of ≤ -1 for age and gender - Short stature, as defined by a height SDS of ≤ -2 for age and gender - Chronological age ≥ 5 years - Bone age ≤ 11 years in boys and ≤ 9 years in girls - GH sufficiency, defined as a maximal stimulated GH response of greater than or equal to 10 ng/mL at Visit 2 (note: upon approval of the Medical Monitor, the result of a prior GH stimulation test may satisfy this requirement). - Prepubertal status - Adequate nutrition as evidenced by a body mass index (BMI) greater than or equal to the 5th percentile for age and gender Exclusion Criteria: - Severe Primary IGFD (defined as height and IGF-1 SDS ≤ 3, and stimulated GH response greater than or equal to 10 ng/mL) - Prior or current use of medications with the potential to alter growth patterns including GH, IGF-1, IGFBP-3, gonadotrophin agonists (e.g., Lupron), aromatase inhibitors, androgens and estrogens - Known or suspected allergy to rhGH, rhIGF-1 or a constituent of their formulations - Current use of medications for attention deficit disorder - A chronic health condition that requires anti-inflammatory steroids or daily medication unless approved by the Medical Monitor


NCT ID:

NCT00572156


Primary Contact:

Study Director
Catherine Lesage, M.D.
Ipsen (formerly Tercica, Inc.)


Backup Contact:

N/A


Location Contact:

Brisbane, California 94005
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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