CompletedPhase 2/3

Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With IGF-1 Deficiency

United States45 participantsStarted 2005-07

Plain-language summary

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.

Who can participate

Age range3 Years

SexALL

See this in plain English?

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

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.

What they're measuring

Height Velocity From Pretreatment (Week 0) to Week 34

Timeframe: Pretreatment to Week 34

Height Velocity From Week 34 to 86

Timeframe: Week 34 to 86

Trial details

NCT IDNCT00125190

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-01

Results submitted2010-03-23

View on ClinicalTrials.gov More Insulin-Like Growth Factor-1 Deficiency trials