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

Hyperinsulinism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004699
• Other study ID #: 199/13381
• Secondary ID: CHP-FDR001181-DR
• Status: Completed
• Phase: N/A
• First received: February 24, 2000
• Last updated: March 24, 2015
• Start date: August 1995
• Est. completion date: January 1999

Study information

• Verified date: March 1999
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperinsulinism

Intervention

Drug:
• insulin-like growth factor I

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia