Phase 3
Completed N=45
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
Source: ClinicalTrials.gov NCT00125190 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Apr 2010
Primary outcomePrimary: Height Velocity From Pretreatment (Week 0) to Week 34 — 7.0 centimeters per year (cm/yr)
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.
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 | — |
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.
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. Informational only — not medical advice.