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Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

Primary Purpose

Hyperinsulinism

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
insulin-like growth factor I
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperinsulinism focused on measuring endocrine disorders, hyperinsulinism, rare disease

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    Children's Hospital of Philadelphia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004700
    Brief Title
    Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Hospital of Philadelphia

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study. Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperinsulinism
    Keywords
    endocrine disorders, hyperinsulinism, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    16 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    insulin-like growth factor I

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pinchas Cohen
    Organizational Affiliation
    Children's Hospital of Philadelphia
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

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