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

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT00004699
Collaborator
(none)
8
Enrollment
41
Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES:
  1. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.
Condition or Disease Intervention/Treatment Phase
  • Drug: insulin-like growth factor I
 N/A

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

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Study Start Date :
Aug 1, 1995
Study Completion Date :
Jan 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Weeks to 3 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia

    Investigators

    • Study Chair: Pinchas Cohen, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00004699
    Other Study ID Numbers:
    • 199/13381
    • CHP-FDR001181-DR
    First Posted:
    Feb 25, 2000
    Last Update Posted:
    Mar 25, 2015
    Last Verified:
    Mar 1, 1999
    Keywords provided by , ,
    endocrine disorders
    hyperinsulinism
    rare disease
    Additional relevant MeSH terms:
    Hyperinsulinism
    Mitogens

    Study Results

    No Results Posted as of Mar 25, 2015