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

Children's Hospital of Philadelphia0 个研究点目标入组 8 人开始时间: 1995年8月1日最近更新: 2015年3月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Children's Hospital of Philadelphia
入组人数: 8

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型: Interventional
主要目的: Treatment

入排标准

年龄范围: 3 Weeks 至 3 Months（Child）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

未提供

研究者

发起方

Children's Hospital of Philadelphia

申办方类型

Other

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