Rabin Medical Center
This study is a randomized, open-label, active controlled, parallel group study comparing the efficacy and safety of once weekly Somatrogon to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature either born Small for Gestational Age (SGA) or with Idiopathic Short Stature (ISS). The planned study duration is 12 months with a screening period of up to 30 days. The study will consist of two groups: 140 children with SGA who are naïve to GH treatment will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months. A second group will include 114 children with ISS who are naïve to GH treatment who will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months.
Inclusion Criteria: 1. Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and/or length \<-2 SDS below the mean for gestational age. ISS, defined as height \< -2 SDS for age and gender without evidence of GHD 2. Females aged ≥3 years and \<9 years. Males aged ≥3 years and \<11 years 3. Pre-pubertal- Tanner stage 1 for breasts and testes. 4. A bone age of not more than chronological age recorded in previous 8 weeks. 5. Current height \< -2 SDS for age and gender. 6. Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone l…
Once weekly Growth Hormone
Daily Growth Hormone