Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004700
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Phase II Long Term Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Sponsor:
Childrens Hospital of Philadelphia
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1999-03
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:
OBJECTIVES
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo controlled cross-over study
Patients are randomized to receive recombinant human insulin-like growth factor I IGF-I or placebo subcutaneously twice daily for 4 weeks After a 2 week washout period patients are crossed over to the other regimen for an additional 4 weeks
Completion date provided represents the completion date of the grant per OOPD records
Patients are randomized to receive recombinant human insulin-like growth factor I IGF-I or placebo subcutaneously twice daily for 4 weeks After a 2 week washout period patients are crossed over to the other regimen for an additional 4 weeks
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHP-FDR001181-DBPC | None | None | None |