Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00330668
Status:
TERMINATED
Last Update Posted:
2020-08-14
First Post:
2006-05-26
Brief Title:
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
Recombinant Human Insulin-Like Growth Factor-1 IGF-1 Treatment of Children With Growth Failure Associated With Primary IGF-1 Deficiency An Open-Label Multi-Center Extension Study
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unacceptable frequency of hypoglycemia observed at and above 200 ugkgday
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an extension study to Tercica study MS301 NCT00125164 and is intended to collect long term safety and efficacy data on the continued use of recombinant human insulin-like growth factor-1 rh IGF-1 in children and adolescents treated for primary IGF-1 deficiency IGFD The secondary objective is to use the data collected to learn more about the relationship of IGF-1 exposure to the promotion of normal growth and pubertal development
Detailed Description:
Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action In this protocol subjects that have completed one year of mecasermin treatment on Tercica protocol MS301 NCT00125164 will be allowed to enroll in this extension study All subjects were planned to receive treatment
This is a Phase IIIb open-label multi-center parallel dose extension study conducted in approximately 40 centers across the United States
This is a Phase IIIb open-label multi-center parallel dose extension 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 |
|---|---|---|---|
| 2019-000844-81 | EUDRACT_NUMBER | None | None |