Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125164
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2005-07-27
Brief Title:
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 IGF-1 Deficiency
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
Recombinant Human Insulin-Like Growth Factor rhIGF-1 Treatment of Prepubertal Children With Growth Failure Associated With Primary IGF-1 Deficiency A Phase 3 Randomized Open Label Observation-Controlled Multicenter Parallel-Dose Comparison Trial
Status:
COMPLETED
Status Verified Date:
2019-09
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:
None
Brief 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
Detailed Description:
Prepubertal growth failure associated with primary IGF-1 deficiency IGFD Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action In this protocol primary IGFD is defined as short stature height standard deviation scoreSDS-2 below the mean for age and gender low serum IGF-1 IGF-1 SDS -2 below the mean for age and gender and levels of growth hormone GH that are normal 7ngmL after a GH stimulation test Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH ie a type of GH insensitivity or GH resistance
This trial is one year randomized open label observation-controlled parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States
This trial is one year randomized open label observation-controlled parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001020-36 | EUDRACT_NUMBER | None | None |