Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Not Applicable
Completed
- Conditions
- Hyperinsulinism
- Registration Number
- NCT00004699
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method