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

This study is ongoing, but not recruiting participants.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Children's Hospital of Philadelphia
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004699

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

Drug Information available for: Insulin Insulin-like growth factor I Mecasermin rinfabate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Efficacy Study

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

Estimated Enrollment:	8
Study Start Date:	May 1998

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.

Eligibility

Ages Eligible for Study:	up to 3 Months
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004699

Sponsors and Collaborators

FDA Office of Orphan Products Development

Children's Hospital of Philadelphia

Investigators

Study Chair:

Pinchas Cohen

Children's Hospital of Philadelphia

More Information

No publications provided

Study ID Numbers:	199/13381, CHP-FDR001181-DR
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004699 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

endocrine disorders
hyperinsulinism
rare disease

Study placed in the following topic categories:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Rare Diseases
Mitogens

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hyperinsulinism
Hypoglycemic Agents
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Mitosis Modulators
Mitogens
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009