Short Children Born Small for Gestational Age (SGA) Clinical Trial
Official title:
Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)
This study is performed as part of the Marketing Authorisation Holder's post-marketing pharmacovigilance plan to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).
The purpose of this study is
1. to monitor short children born SGA who were treated with growth hormone in study
EP00-401 for the development of diabetes for a further 10 years after termination of
growth hormone treatment
and
2. to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP)
antibodies (ABs) for 6 months after termination of GH treatment.
;