Title
Long-Term Treatment With rhIGF-1 in GHIS
A Study of Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)
Phase
Phase 2/Phase 3Lead Sponsor
IpsenStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Growth Hormone Insensitivity SyndromeIntervention/Treatment
mecasermin ...Study Participants
92The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).
injections BID of rhIGF-1, mecasermin
Inclusion Criteria: Height <-2SD for age and gender IGF-1 <-2SD for age and gender Evidence of GH resistance Exclusion Criteria: closed epiphyses prior active malignancy major organ disfunction treatment with medications that would diminish growth clinically significant cardiac abnormalities
| Event Type | Organ System | Event Term | Mecasermin |
|---|
Height velocity is the difference between 2 height measurements, divided by years elapsed between measurements.
Height measurements were performed using wall-mounted stadiometers for analysis of growth data.
Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height velocity-standard deviation score was calculated as height velocity minus reference mean height velocity divided by standard deviation of the reference mean height velocity. Greater height velocity standard deviation score indicates better outcome.
Center for disease control growth charts from the US were used as reference for age and gender-dependent mean and standard deviation. Height standard deviation score was calculated as height minus reference mean height divided by standard deviation of the reference mean height. A higher height standard deviation score indicates a better outcome.
Height measurements were performed using wall-mounted stadiometers for analysis of growth data.
