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

Study acronym: MISSION
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 6 → 32 locations
    • Start date changed from estimate of Feb 2026 to Feb 1, 2026
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 6 of 6 sites
    v3
  3. Minor Secondary endpoints: details revised at 1 of 6 entries
    • Site details revised at 1 of 6 sites
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07226089
Lead Sponsor Rabin Medical Center
Collaborators: Pfizer
Conditions
(from sponsor)
ISS, SGA
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov