Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
Condition(s) studied
Investigational drug(s) / intervention(s)
Somatrogon: Once weekly Growth Hormone
Genotropin: Daily Growth Hormone
Study 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 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
Primary outcome measure(s)
- Annual Height Velocity — • Annualized HV after 12 months of treatment
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Trial sites (32)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California Los Angeles (UCLA) - Mattel Children's Hospital | Los Angeles | California | Not Yet Recruiting |
| Rocky Mountain Pediatric Endocrinology | Centennial | Colorado | Not Yet Recruiting |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | Not Yet Recruiting |
| Children's Minnesota - Minneapolis | Minneapolis | Minnesota | Not Yet Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | Not Yet Recruiting |
| Atlantic Health System | Morristown | New Jersey | Not Yet Recruiting |
| Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey | New Brunswick | New Jersey | Not Yet Recruiting |
| The State University of New York (SUNY) School of Medicine and Biomedical Sciences | Buffalo | New York | Not Yet Recruiting |
| Hassenfeld Children's Hospital at NYU Langone | New York | New York | Not Yet Recruiting |
| Dell Children's Medical Group | Austin | Texas | Not Yet Recruiting |
| Cook Children's Medical Center | Fort Worth | Texas | Not Yet Recruiting |
| The University of Utah | Salt Lake City | Utah | Not Yet Recruiting |
| Centre Hospitalier Universitaire d'Angers | Angers | France | Not Yet Recruiting |
| Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Not Yet Recruiting |
| Chu de Lyon - Hopital Femme Mere Enfant | Lyon | France | Not Yet Recruiting |
| CHU Hôpital de la Timone | Marseille | France | Not Yet Recruiting |
| Hôpital Armand-Trousseau | Paris | France | Not Yet Recruiting |
| Hôpital Necker - Enfants Malades | Paris | France | Not Yet Recruiting |
| Jehangir Hospital | Maheshra | India | Not Yet Recruiting |
| Apollo Hospitals Enterprise Limited | Navi Mumbai | India | Not Yet Recruiting |
| All India Institute of Medical Sciences (AIIMS) - New Delhi | New Delhi | India | Not Yet Recruiting |
| Sir Ganga Ram Hospital | New Delhi | India | Not Yet Recruiting |
| Schneider Children Medical Center- the institute of Endocrinology and Diabetes | Petah Tikva | Israel | Recruiting |
| Shaare Zedek Medical Center | Jerusalem | Israe | Not Yet Recruiting |
| Soroka hospital | Bear Sheva | Israel | Not Yet Recruiting |
| Sheba Medical Center | Ramat Gan | Israel | Not Yet Recruiting |
| Assaf Harofe Medical Center | Rishon LeZiyyon | Israel | Not Yet Recruiting |
| Dana-Duek children's hospital | Tel Aviv | Israel | Not Yet Recruiting |
| Osaka Women's and Children's Hospital | Izumi-Shi | Japan | Not Yet Recruiting |
| Nara Prefecture General Medical Center | Nara | Japan | Not Yet Recruiting |
| Osaka City General Hospital | Osaka | Japan | Not Yet Recruiting |
| National Center for Child Health and Development | Setagaya-Ku | Japan | Not Yet Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07226089 on ClinicalTrials.gov ↗ ← All trials in France