rhGH and rhIGF-1 Combination Therapy in Children With Short Stature Associated With IGF-1 Deficiency
Status:
Terminated
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
IGF-1 (insulin-like growth factor-1) is a hormone that is normally produced in the body in
response to another hormone called growth hormone. Growth Hormone is produced by a small
gland at the base of the brain (the pituitary). Together IGF-1 and GH are large contributors
to growth during infancy, childhood, and adolescence.
Children with IGF Deficiency are short and have an imbalance in the levels of growth hormone
and IGF-1 that their body produces. Their growth hormone levels are normal or even high, but
IGF-1 levels do not increase normally in response to growth hormone. As a result, they have a
type of growth hormone insensitivity and an inability to grow normally.
This study is a test to see whether daily dosing with a combination of rhIGF-1 and rhGH will
help children with IGFD grow taller more quickly than children treated with rhGH alone. The
study medications, rhIGF-1 and rhGH, are approved by the US Food and Drug Administration
(FDA) for use in some growth disorders in children, but the combination of rhIGF-1 and rhGH
in children with IGF-1 deficiency (IGFD) is investigational.