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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: Insulin; Insulin, Globin Zinc; Mecasermin; Mitogens

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.