Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488124
Status:
COMPLETED
Last Update Posted:
2020-12-14
First Post:
2007-06-18
Brief Title:
Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin
Sponsor:
University of Erlangen-Nürnberg Medical School
Organization:
University of Erlangen-Nürnberg Medical School
Study Overview
Official Title:
Evaluation of Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin A Prospective Longitudinal Non-randomised Open Phase II Study
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISS
Brief Summary:
Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation Growth hormone therapy will show an increase in height velocity 1 SD compared to pretreatment height velocity and the therapy will be safe
Detailed Description:
Growth hormone GH Somatropin eg Genotropin is approved in the treatment of children in specific indications However besides the benefit in approved indications a benefit can also be achieved in other pathological conditions that lead to growth retardation However because of their relative low frequency and the long duration of GH studies in children few data or only case reports on GH treatment are available in these conditions Nevertheless published data have suggested a benefit of GH treatment in children suffering from some of those diseases and pediatric endocrinologists sometimes request GH treatment for those children to improve growth rate This protocol is designed to allow such children with severe growth retardation to be treated with GH and will allow those children to be carefully followed-up and finally evaluated at the end of the GH treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None