About this trial
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.
Eligibility criteria
Qualifiers
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
Females aged ≥3 years and <9 years. Males aged ≥3 years and <11 years
Pre-pubertal- Tanner stage 1 for breasts and testes.
A bone age of not more than chronological age recorded in previous 8 weeks.
Disqualifiers
History of cancer, radiation therapy or chemotherapy.
History of GHD.
Children who are small due to malnutrition, defined as a Z score of weight for height and/or BMI below -2 for age, according to national standards.
History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis.
Trial design
Treatments tested in this trial
- Somatrogon
- Genotropin
Treatment groups
Sponsors and collaborators
Rabin Medical Center
Lead sponsor
Pfizer
Collaborator