Phase II Long Term, Randomized Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism
Evaluate the safety and efficacy of long term recombinant human insulin-like growth factor I in children with hyperinsulinism.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||August 1995|
|Estimated Study Completion Date:||January 1999|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004700
|Study Chair:||Pinchas Cohen||Children's Hospital of Philadelphia|