Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Phase 2
Completed
- Conditions
- Hyperinsulinism
- Registration Number
- NCT00004700
- Lead Sponsor
- Children's Hospital of Philadelphia
- Brief Summary
OBJECTIVES:
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method