Long-term Safety Follow-up After Growth Hormone Treatment of Short Children Born Small for Gestational Age

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.

Inclusion Criteria:

• All patients who fulfilled the diagnosis SGA, participated in study EP00-401, and received at least one dose of study medication
• Written informed consent of patient (for children who can read and/ or understand) and/or parent or legal guardian

Exclusion Criteria:

• Patients unwilling and/or parents/guardians who are not capable of ensuring compliance with the provisions of the study protocol