Overview

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

Status:
NOT_YET_RECRUITING

Trial end date:
2028-01-01

Target enrollment:

Participant gender:

Summary

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 nave 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 nave to GH treatment who will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months.

Phase:

PHASE3

Details

Lead Sponsor:

Rabin Medical Center

Collaborator:

Pfizer

Treatments:

Human Growth Hormone
somatrogon