A Phase 2, Six-Month Safety and Efficacy Study of TransCon hGH Compared to Daily hGH in Pre-Pubertal Children with Growth Hormone Deficiency (GHD)
Date
2016-04-01
Authors
Senatorova, Ganna
Chatelain, Pierre
Malievsky, Oleg
Radziuk, Klaudziya
Skorodok, Julia
Abdou, Magdy Omar
Peterkova, Valentina
Vlachopapadopoulou, Elpis
Beckert, Michael
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
This study demonstrates the safety and efficacy of TransCon hGH in children with GHD over a treatment period of six months. Safety and efficacy (annualized height velocity), as well as PK and PD data of 53 GHD patients treated over a six-month period with TransCon hGH or daily hGH will be presented. All TransCon hGH doses demonstrated an excellent safety (comparable to daily hGH) and local tolerability profile (only mild and sporadic reactions comparable to daily hGH / no nodule formation and lypodystrophy) and an excellent growth within the expected ranges - mean annualized height velocities ranging between 11.9 cm to 13.9 cm for the different dose levels of TransCon hGH compared to 11.6 cm mean annualized height velocity for daily hGH treatment.
Description
Keywords
TransCon hGH, pre-pubertal children
Citation
A Phase 2, Six-Month Safety and Efficacy Study of TransCon hGH Compared to Daily hGH in Pre-Pubertal Children with Growth Hormone Deficiency (GHD) / P. Chatelain, O. Malievsky, K. Radziuk, G. Senatorova, Ju. Skorodok, M. O. Abdou, V. Peterkova, E. Vlachopapadopoulou, M. Beckert // Endocrine Society's 98th Annual Meeting and Expo, Boston, April 1–4, 2016. – Режим доступа: http://press.endocrine.org/doi/abs/10.1210/endo-meetings.2016.PE.3.OR31-5.