Expired Study
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Brisbane, California 94005


Purpose:

This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.


Study summary:

Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (height standard deviation score[SDS]<-2 below the mean for age and gender), low serum IGF-1 (IGF-1 SDS <-2 below the mean for age and gender), and levels of growth hormone (GH) that are normal (≥7ng/mL) after a GH stimulation test. Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH, i.e., a type of GH insensitivity or GH resistance. This trial is one year, randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States.


Criteria:

Inclusion Criteria: - Chronological age ≥ 3 and chronological or bone age less than or equal to 11 years inclusive in girls; - Chronological age ≥ 3 and chronological or bone age less than or equal to 12 years inclusive for boys - Prepubertal - Height SD score of < -2 - IGF-1 SD score of < -2 Exclusion Criteria: - Prior treatment with rhGH, rhIGF-1, or other growth-influencing medications - Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality) - Chronic illness such as diabetes, cystic fibrosis, etc.


NCT ID:

NCT00125164


Primary Contact:

Study Director
Ipsen Study Director, M.D.
Ipsen


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: December 18, 2017

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