CompletedPhase 3

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

United States137 participantsStarted 2004-03

Plain-language summary

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.

Who can participate

Age range3 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Height Velocity During the First Year - Intent to Treat (ITT)Population

Timeframe: Measured at baseline and at one year

Trial details

NCT IDNCT00125164

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-07

Results submitted2009-07-08

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