hrp0084p3-938 | GH & IGF | ESPE2015

An Open-Label Phase 2 Dose-Finding Study Comparing Three Different Doses of Weekly TV-1106 and Daily Recombinant Human GH (Genotropin®) in Treatment-Naive, Pre-Pubertal, GH-Deficient Children

Rosenfeld Ron G , Wit Jan M , Malievsky Oleg , Bolshova Elena , Brown Kurt , Sakov Anat , Anscheutz Gaya , Bassan Merav , Butler Kathleen

Background: TV-1106 (Teva Pharmaceuticals) is a genetically fused human GH and human serum albumin, in development for treatment of GH deficiency (GHD). TV-1106 has an extended duration of action compared to daily GH treatment and thus it is believed that treatment with TV-1106 can reduce the frequency of injections and improve compliance and quality of life for those requiring growth hormone replacement therapy. The efficacy and safety data from adult studies with TV-1106 sup...

hrp0089rfc4.5 | GH & IGFs | ESPE2018

12-Month Effects of Once-Weekly and Twice-Monthly Administration of Hybrid Fc-Fused Human Growth Hormone, GX-H9, Treatment in Pediatric with GHD Deficiency

Malievskiy Oleg , Mykola Aryaev , Nataliya Zelinska , Bolshova Elena V , Senatorova Ganna , Oroszlan Gyorgy , Skorodok Julia , Peterkova Valentina , Nataliya Chorna , Sorokman Tamila , Yang Seung , Lee Ji Eun , Muzsnai Agota , Hwang Jin Soon , Lee Sang Yoon , Choi Yun Jung , Ji Hyi-Jeong , Woo Jungwon , Sung Young-Chul

GX-H9 is a long-acting form of recombinant human GH under clinical development for both adults and children with GH deficiency (GHD). This study was designed to compare 12-month effects of once-weekly and twice-monthly (every other week; EOW) administration of GX-H9 treatment to that of Genotropin®, in pediatric patients with GHD. A randomized, open-label, active-controlled, parallel study was conducted at 27 endocrinology centers in 10 countries (Europe and Ko...