Phase 3 N=45 Treatment

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

Insulin-Like Growth Factor-1 Deficiency · Growth Disorders

Bottom Line

View on ClinicalTrials.gov: NCT00125190 ↗

Enrolled (actual)

Serious AEs

4.4%

Results posted

Apr 2010

Primary outcome: Primary: Height Velocity From Pretreatment (Week 0) to Week 34 — 7.0 centimeters per year (cm/yr)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: rhIGF-1 (mecasermin) for a period of 86 weeks (Drug)
Age: Pediatric, Adult, Older Adult · 3+ yrs
Sex: All
Sponsor: Ipsen
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Height Velocity From Pretreatment (Week 0) to Week 34	7.0	—
PRIMARY Height Velocity From Week 34 to 86	6.7	—
SECONDARY Change in Height SD Score From Pretreatment to Week 34	0.21	—
SECONDARY Change in Height SD Score From Pretreatment to Week 86	0.45	—
SECONDARY Change in Bone Age From Pretreatment to Week 86 Minus Change in Chronological Age	0.2	—
SECONDARY Percent Change in Serum Concentration of IGFBP-1, IGFBP-2 and IGFBP-3 From Pretreatment to Week 86	-89.6; 37.9; 0	—
SECONDARY Percent Change in Serum Concentration of ALS From Pretreatment to Week 86	-7.7	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00125190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.