Dose Ranging Study of Recombinant Human Insulin-Like Growth Factor I in Children With Hyperinsulinism
Recruitment status was Active, not recruiting
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:||May 1998|
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.
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|