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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Somatrogon
DrugOnce weekly Growth Hormone
Genotropin
DrugDaily Growth Hormone
Treatment groups
Trial outcomes
Primary outcomes
Annual Height Velocity
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Secondary outcomes
Height Velocity over time
height SDS
Changes in height Standard Deviation Score (SDS)
Bone maturation
Annual change in bone age measurements as per Gruelich-Pyle method
Insulin-like Growth Factor-1 (IGF-1)
Via central lab analysis
Other outcomes
IGFBP-3
Via central lab
Frequency of abnormal lab results in the Somatrogon arm
SAE's in the Somatrogon arm
AE's in the Somatrogon arm
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rabin Medical Center
Lead sponsor
Pfizer
Collaborator