NCT00004700

Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (planned)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hyperinsulinism

Interventions

Type	Name	Description
DRUG	insulin-like growth factor I

Timeline

• Start date: 1995-08-01
• Completion: 1999-01-01
• First posted: 2000-02-25
• Last updated: 2015-03-25