Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004699
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2000-02-24
Brief Title:
Dose Ranging 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
I Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia
I Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia
Detailed Description:
PROTOCOL OUTLINE This is a dose escalation study Patients receive an escalating dose of recombinant human insulin-like growth factor I IGF-I IGF-I is given subcutaneously twice a day The dose of IGF-I is increased each day for 4 days Glucose is administered intravenously when necessary to prevent hypoglycemia
Following the study treatment patients resume prior medication and may undergo surgery
Completion date provided represents the completion date of the grant per OOPD records
Following the study treatment patients resume prior medication and may undergo surgery
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-DR | None | None | None |