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



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

For Condition: Hyperinsulinism
Status: No longer recruiting
Sponsor(s): FDA Office of Orphan Products Development , Children's Hospital of Philadelphia
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Efficacy Study
Minimum Age/Maximum Age: /3 Months
Genders: Both
Protocol Entry 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
Total Enrollment: 8

Location and Contact Information:

Overall Study Official:
PinchasCohen,  Study Chair,  Children's Hospital of Philadelphia


Additional Information:
Study ID Numbers:
  199/13381;  CHP-FDR001181-DR
Study Start Date: May 1998
Record last reviewed: March 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004699

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