drugset / Trial / NCT00125164
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency
RandomizedParallel-groupOpen-labelTreatment
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
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 |