Trial | NCT00571727  Report issue

Title

Long-Term Treatment With rhIGF-1 in GHIS
A Study of the Long-Term Human Recombinant Insulin-Like Growth Factor-1 (rhIGF-1) Treatment in Children With Short Stature Due to Growth Hormone Insensitivity Syndrome (GHIS)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    mecasermin ...

  • Study Participants

    92
Long term study of the effects of dosing with rhIGF-1 on growth
Study Started
Jan 31
1990
Primary Completion
Oct 31
2004
Study Completion
Dec 31
2011
Last Update
Jan 07
2019

Drug mecasermin

injections BID of rhIGF-1, mecasermin

  • Other names: Increlex

mecasermin, injections BID of rhIGF-1 Experimental

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
No Results Posted