Long-Term Treatment With rhIGF-1 in GHIS

Completed · Phase 2/Phase 3

Conditions studied: Growth Hormone Insensitivity Syndrome

In brief

The objective of this study was to evaluate the long-term safety and effectiveness of mecasermin (the study drug) in children with growth failure due to severe Primary insulin-like growth factor-1 deficiency (Primary IGFD).

Key facts

Study ID

NCT00571727

Run by

Ipsen

People needed

92

Starts

1991-05-20

Expected to finish

2011-12-15

Last updated by the study team

2023-07-06

Who can join

Age: 2 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Height <-2SD for age and gender
• IGF-1 <-2SD for age and gender
• Evidence of GH resistance

You may not qualify if…

• closed epiphyses
• prior active malignancy
• major organ disfunction
• treatment with medications that would diminish growth
• clinically significant cardiac abnormalities

Where it is running

• Ipsen — Brisbane, California, United States

Full record on ClinicalTrials.gov

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