clinical trial · NCT00537914
Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
Sandoz·phase4·completed·n = 278
Small for Gestational AgeOmnitrope
brief summary
This study is performed 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).
started
Feb 6, 2008
primary completion
Mar 25, 2022
completion
Mar 25, 2022
last updated
Mar 12, 2024
detailed description
Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.
official title
Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol