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

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Hyperinsulinism

Treatments: Drug: insulin-like growth factor I

Study type: Interventional

Funder types: Other

Identifiers

NCT00004699

CHP-FDR001181-DR

199/13381

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 3 weeks to 3 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)
• Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL)
• Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia
• No other major medical problems