Long-term Safety Follow-up After Growth Hormone Treatment 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).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Long-term Safety Follow-up After Growth Hormone Treatment (rhGH) of Short Children Born Small for Gestational Age (SGA)|
- Evaluate the long-term effect of growth hormone treatment on the development of diabetes after end of therapy. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]The primary objective of this study is to evaluate the long-term effect of growth hormone treatment on the development of diabetes in short children born SGA for 10 years after the end of treatment.
- To evaluate the incidence of anti-rhGH antibodies and anit-HCP antibodies after 6 months after termination of growth hormone treatment. [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
The secondary objectives of this study are:
- to report the incidence of anti-rhGH antibodies and of E. coli host cell peptide (HCP) antibodies (ABs) 6 months after termination of growth hormone treatment.
- to evaluate final height in follow-up period
- to evaluate IGF-I and IGFBP-3 levels for 10 years after end of growth hormone treatment
- to evaluate incidence and severity of adverse events
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||July 2031|
|Estimated Primary Completion Date:||July 2031 (Final data collection date for primary outcome measure)|
Monitoring of long-term safety
Long-term safety follow-up after the end of treatment with Omnitrope (single arm)
The purpose of this study is
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491854
|Contact: Sandoz Biopharmaceuticals||+49 8024 908 ext 0|
|Prague, Czech Republic|
|St. Augustin, Germany|
|Study Chair:||Sandoz Biopharmaceuticals Sandoz||Sandoz GmbH|