Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351221
Status:
TERMINATED
Last Update Posted:
2007-03-30
First Post:
2006-07-11
Brief Title:
Research Study Using Recombinant Human Insulin-Like Growth Factor-1Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
Sponsor:
Insmed Incorporated
Organization:
Insmed Incorporated
Study Overview
Official Title:
A Phase 2 Open-Label Multicenter Clinical Trial to Evaluate the Pharmacokinetics Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome
Status:
TERMINATED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to a patent legal settlement
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The trial will investigate the treatment of growth failure in children with Noonan syndrome Abnormalities in the growth hormone GH - insulin-like growth factor-I IGF-I axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis and hopefully improve body growth
Detailed Description:
None
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