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

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 23, 2005

Start Date ^ICMJE

May 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004699 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Efficacy Study

Condition ^ICMJE

Hyperinsulinism

Intervention ^ICMJE

Drug: insulin-like growth factor I

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 3 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004699

Responsible Party

Study ID Numbers ^ICMJE

199/13381, CHP-FDR001181-DR

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Children's Hospital of Philadelphia

Investigators ^ICMJE

Study Chair:

Pinchas Cohen

Children's Hospital of Philadelphia

Information Provided By

FDA Office of Orphan Products Development

Verification Date

March 1999

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP