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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004699
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
FDA Office of Orphan Products Development
  Purpose

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.


Condition Intervention
Hyperinsulinism Drug: insulin-like growth factor I

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 8
Study Start Date: August 1995
Estimated Study Completion Date: January 1999
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004699


Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Study Chair: Pinchas Cohen Children's Hospital of Philadelphia
  More Information

ClinicalTrials.gov Identifier: NCT00004699     History of Changes
Other Study ID Numbers: 199/13381
CHP-FDR001181-DR
First Submitted: February 24, 2000
First Posted: February 25, 2000
Last Update Posted: March 25, 2015
Last Verified: March 1999

Keywords provided by FDA Office of Orphan Products Development:
endocrine disorders
hyperinsulinism
rare disease

Additional relevant MeSH terms:
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Mitogens
Complement Factor I
Mecasermin
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Growth Substances