Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency

Completed · Phase 3

Conditions studied: Growth Disorders, Insulin-Like Growth Factor-1 Deficiency

In brief

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.

Key facts

Study ID

NCT00125164

Run by

Ipsen

People needed

137

Starts

2004-03-01

Expected to finish

2008-07-01

Last updated by the study team

2019-09-18

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ipsen (formerly Tercica) — Brisbane, California, United States

Full record on ClinicalTrials.gov

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