Long-Term Treatment With rhIGF-1 in GHIS

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Long term study of the effects of dosing with rhIGF-1 on growth

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Collaborator: University of Oklahoma
• Treatments: Mecasermin

Criteria

Inclusion Criteria:

• Height <-2SD for age and gender

• IGF-1 <-2SD for age and gender

• Evidence of GH resistance

Exclusion Criteria:

• closed epiphyses

• prior active malignancy

• major organ disfunction

• treatment with medications that would diminish growth

• clinically significant cardiac abnormalities