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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004699
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: March 1999
  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: Endpoint Classification: Efficacy Study
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

Ages Eligible for Study:   up to 3 Months   (Child)
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 24, 2000
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

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
Hypoglycemic Agents
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 25, 2016