NCT00004699

Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (planned)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 3 Weeks – 3 Months
• Healthy volunteers: Not accepted

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.

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

Conditions

• Hyperinsulinism

Interventions

Type	Name	Description
DRUG	insulin-like growth factor I

Timeline

• Start date: 1995-08-01
• Completion: 1999-01-01
• First posted: 2000-02-25
• Last updated: 2015-03-25