NCT01491854

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Short Children Born Small for Gestational Age (SGA)

Interventions

Type	Name	Description
OTHER	Bloodsampling	Bloodsampling

Timeline

• Start date: 2009-07-20
• Primary completion: 2018-10-31
• Completion: 2018-10-31
• First posted: 2011-12-14
• Last updated: 2019-08-14
• Results posted: 2019-08-14

Locations

23 sites across 6 countries: Czechia, Georgia, Germany, Hungary, Poland, Romania