At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 45 enrolled
Drug / intervention
rhIGF-1 (mecasermin) for a period of 86 weeksdrug
Likely dose
rhIGF-1 (mecasermin) once daily by injection for 86 weeksAI-extracted
Key inclusion· 4
- ✓Age 3 to 12 years (boys) or 3 to 11 years (girls)
- ✓Prepubertal at baseline
- ✓Height SD score < −2
- ✓IGF-1 SD score < −2
Key exclusion· 3
- ✕Prior treatment with growth hormone, IGF-1, or other growth-influencing medications
- ✕Growth failure from other identifiable causes (syndromes, chromosomal abnormalities)
- ✕Chronic illness such as diabetes or cystic fibrosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Recombinant Human Insulin-Like Growth Factor (rhIGF-1) Treatment of Short Stature Associated With Primary IGF-1 Deficiency: A Multi-Center, Open Label, Concentration-Controlled Study
In Brief
A Phase 3 clinical trial evaluating rhIGF-1 (mecasermin) for a period of 86 weeks for Insulin-Like Growth Factor-1 Deficiency and Growth Disorders. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
First PostedJul 2005
Primary CompletionJan 2009
TodayJul 2026
First PostedJul 29, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 20.9 years ago
Interventions
rhIGF-1 (mecasermin) for a period of 86 weeksdrug
Once a day rhIGF-1 injections