Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
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.
Timeline
- Start
- 2004-03
- Primary completion
- 2008-07
- Completion
- 2008-07
Outcome
Met primary endpoint
registry analysis (unspecified test); Untreated vs 80 μg/kg BID (Twice Daily Dosing); p <0.0001; LS mean difference 1.79 (95% CI 1.19 to 2.39); ANCOVA NCT00125164 ↗
registry analysis (unspecified test); Untreated vs 120 μg/kg BID (Twice Daily Dosing); p < 0.0001; LS mean difference 2.58 (95% CI 1.99 to 3.16); ANCOVA NCT00125164 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | mecasermin | Protein / enzyme biologic | 40 ug/kg | Other |
| Subject | mecasermin | Protein / enzyme biologic | 80 ug/kg | Other |
| Subject | mecasermin | Protein / enzyme biologic | 120 ug/kg | Other |