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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Mecasermin; Mitogens

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.