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Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone
Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 11
Healthy Volunteers: f
View:
• 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.
• Current height \< -2 SDS for age and gender.
• Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Locations
United States
California
University of California Los Angeles (UCLA) - Mattel Children's Hospital
NOT_YET_RECRUITING
Los Angeles
Colorado
Rocky Mountain Pediatric Endocrinology
NOT_YET_RECRUITING
Centennial
Florida
Nemours Children's Clinic - Jacksonville
NOT_YET_RECRUITING
Jacksonville
Minnesota
Children's Minnesota - Minneapolis
NOT_YET_RECRUITING
Minneapolis
New Jersey
Hackensack University Medical Center
NOT_YET_RECRUITING
Hackensack
Atlantic Health System
NOT_YET_RECRUITING
Morristown
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
NOT_YET_RECRUITING
New Brunswick
New York
The State University of New York (SUNY) School of Medicine and Biomedical Sciences
NOT_YET_RECRUITING
Buffalo
Hassenfeld Children's Hospital at NYU Langone
NOT_YET_RECRUITING
New York
Texas
Dell Children's Medical Group
NOT_YET_RECRUITING
Austin
Cook Children's Medical Center
NOT_YET_RECRUITING
Fort Worth
Utah
The University of Utah
NOT_YET_RECRUITING
Salt Lake City
Other Locations
France
Centre Hospitalier Universitaire d'Angers
NOT_YET_RECRUITING
Angers
Hôpital Bicêtre
NOT_YET_RECRUITING
Le Kremlin-bicêtre
Chu de Lyon - Hopital Femme Mere Enfant
NOT_YET_RECRUITING
Lyon
CHU Hôpital de la Timone
NOT_YET_RECRUITING
Marseille
Hôpital Armand-Trousseau
NOT_YET_RECRUITING
Paris
Hôpital Necker - Enfants Malades
NOT_YET_RECRUITING
Paris
India
Jehangir Hospital
NOT_YET_RECRUITING
Maheshra
Apollo Hospitals Enterprise Limited
NOT_YET_RECRUITING
Navi Mumbai
All India Institute of Medical Sciences (AIIMS) - New Delhi
NOT_YET_RECRUITING
New Delhi
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Israel
Soroka hospital
NOT_YET_RECRUITING
Bear Sheva
Shaare Zedek Medical Center
NOT_YET_RECRUITING
Jerusalem
Schneider Children Medical Center- the institute of Endocrinology and Diabetes
RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Assaf Harofe Medical Center
NOT_YET_RECRUITING
Rishon Leziyyon
Dana-Duek children's hospital
NOT_YET_RECRUITING
Tel Aviv
Japan
Osaka Women's and Children's Hospital
NOT_YET_RECRUITING
Izumi-shi
Nara Prefecture General Medical Center
NOT_YET_RECRUITING
Nara
Osaka City General Hospital
NOT_YET_RECRUITING
Osaka
National Center for Child Health and Development
NOT_YET_RECRUITING
Setagaya-ku
Contact Information
Primary
Moshe Phillip, Professor
mosheph@clalit.org.il
972-54-479-5995
Backup
Alona Hamou, MSc
alonah@clalit.org.il
972-54-595-0277
Time Frame
Start Date:2026-02-01
Estimated Completion Date:2028-01
Participants
Target number of participants:254
Treatments
Experimental: Somatrogon
Somatrogon will be administered subcutaneously (s.c) once weekly using a multi dose disposable prefilled pen for single patient use intended for SC self injection.
Active_comparator: Genotropin
Genotropin will be administrated subcutaneously (s.c) daily using Genotropin Pen growth hormone delivery devices or Genotropin two chamber cartridges (will be supplied in their primary commercial packaging)