NCT00004699

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 1995

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1995

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1999

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 1999

First QC Date

February 24, 2000

Last Update Submit

March 24, 2015

Conditions

Hyperinsulinism

Keywords

endocrine disordershyperinsulinismrare disease

Interventions

insulin-like growth factor IDRUG

Eligibility Criteria

Age3 Weeks - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

HyperinsulinismEndocrine System DiseasesRare Diseases

Interventions

Insulin-Like Growth Factor I

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SomatomedinsInsulin-Like PeptidesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsBlood ProteinsProteinsBiological Factors

Study Officials

  • Pinchas Cohen

    Children's Hospital of Philadelphia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

August 1, 1995

Study Completion

January 1, 1999

Last Updated

March 25, 2015

Record last verified: 1999-03