- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004700
Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
OBJECTIVES:
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross-over study.
Patients are randomized to receive recombinant human insulin-like growth factor I (IGF-I) or placebo subcutaneously twice daily for 4 weeks. After a 2 week washout period, patients are crossed over to the other regimen for an additional 4 weeks.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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) Suboptimal control of blood sugar (i.e., inability to fast at least 10 hours with a blood sugar of 60 mg/dL or greater) --Prior/Concurrent Therapy-- See Disease Characteristics --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other major medical conditions No known adverse reaction to recombinant human insulin-like growth factor I
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Investigators
- Study Chair: Pinchas Cohen, Children's Hospital of Philadelphia
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/13382
- CHP-FDR001181-DBPC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Zealand PharmaCompletedCongenital HyperinsulinismUnited States, United Kingdom, Israel, Germany
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RezoluteCompletedCongenital HyperinsulinismUnited States, Denmark, United Kingdom, Russian Federation, Spain, Bulgaria, Canada, Georgia, Germany, Israel, Turkey
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FDA Office of Orphan Products DevelopmentChildren's Hospital of PhiladelphiaCompleted
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Astellas Pharma IncCompleted
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Children's Hospital of Fudan UniversityCompleted
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Mayo ClinicNational Institute of Neurological Disorders and Stroke (NINDS); ALS Association and other collaboratorsCompletedAmyotrophic Lateral SclerosisUnited States, Puerto Rico
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Massachusetts General HospitalCompletedDisorder of Bone Density and Structure, UnspecifiedUnited States