Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
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.
|Study Design:||Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||August 1995|
|Estimated Study Completion Date:||January 1999|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004699
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|