Expired Study
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Brisbane, California 94005


Purpose:

This study is intended to assess the effects of once daily dosing of recombinant human insulin-like growth factor (rhIGF-1) in increasing height velocity.


Study summary:

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 growth hormone (GH) action. In this protocol, primary IGFD is defined as short stature (<-2 standard deviations [SDs] below the mean for age and gender), and abnormal serum IGF-1 (<-2 SDs below the mean for age and gender). The trial is an open-label, concentration-controlled trial conducted at up to 20 centers throughout the United States.


Criteria:

Inclusion Criteria: - Chronological age ≥ 3 - Chronological age or bone age ≤ 12 for boys and ≤ 11 for girls - Prepubertal at Visit 1 - Height SD score of < -2 - IGF-1 SD score of < -2 Exclusion Criteria: - Prior treatment with GH, IGF-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:

NCT00125190


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 11, 2017

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