Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.

Recruiting Phase 3 Interventional Study
ISS SGA
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 11
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
254 (estimated)
Sponsor
Rabin Medical Center · Other
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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 wil…
Trial Locations
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Eligibility Criteria
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 …
Contacts

Moshe Phillip, Professor

972-54-479-5995

mosheph@clalit.org.il

CONTACT

Alona Hamou, MSc

972-54-595-0277

alonah@clalit.org.il

CONTACT