Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125190
Status:
COMPLETED
Last Update Posted:
2020-07-27
First Post:
2005-07-27
Brief Title:
Recombinant Human Insulin-Like Growth Factor rhIGF-1 Treatment of Short Stature Associated With IGF-1 Deficiency
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2020-07
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 assess the effects of once daily dosing of recombinant human insulin-like growth factor rhIGF-1 in increasing height velocity
Detailed Description:
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 growth hormone GH action In this protocol primary IGFD is defined as short stature -2 standard deviations SDs below the mean for age and gender and abnormal serum IGF-1 -2 SDs below the mean for age and gender
The trial is an open-label concentration-controlled trial conducted at up to 20 centers throughout the United States
The trial is an open-label concentration-controlled trial conducted at up to 20 centers throughout 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 |
|---|---|---|---|
| 2019-001095-11 | EUDRACT_NUMBER | None | None |