Actively Recruiting
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
Led by Rabin Medical Center · Updated on 2026-04-30
254
Participants Needed
32
Research Sites
99 weeks
Total Duration
On this page
Sponsors
R
Rabin Medical Center
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Small for Gestational Age (SGA) or Idiopathic Short Stature (ISS). SGA means born with birth weight and/or length less than -2 standard deviation score (SDS) for gestational age. ISS means height less than -2 SDS for age and gender without growth hormone deficiency.
- Females aged 3 years and under 9 years; males aged 3 years and under 11 years.
- Pre-pubertal status with Tanner stage 1 for breasts or testes.
- Bone age not more than chronological age recorded within 8 weeks before screening.
- Current height less than -2 SDS for age and gender.
- Stable hormonal replacement therapy if used, with hormone levels within normal ranges for at least 3 months prior to screening.
- Willing and able to follow all study visits, treatment plans, lab tests, and procedures.
You will not qualify if you...
- History of cancer, radiation therapy, or chemotherapy.
- History of growth hormone deficiency.
- Small size due to malnutrition, defined as weight for height and/or BMI Z score below -2 for age.
- History of HIV, AIDS, hepatitis B, hepatitis C, or tuberculosis.
- Microcephaly (head circumference less than -2 SDS).
- Chronic diseases or diagnoses likely to affect growth, including gastrointestinal disorders, celiac disease, untreated thyroid disease, diabetes, and metabolic disorders.
- Known or suspected skeletal dysplasias.
- Known or suspected chromosomal abnormalities.
- Insulin-like Growth Factor 1 (IGF-1) level greater than 2 SDS.
- Any condition that might risk participant safety or compliance, as judged by the investigator.
- Prior growth promoting therapy exposure.
- Current use of prohibited medications including growth hormone or growth-promoting therapy, appetite or weight affecting therapy, psychiatric medications affecting weight or diabetes (except ADHD medications), androgen or estrogen therapy including supplements, and high-dose corticosteroids.
- Use of investigational drugs within 90 days.
- Fasting blood glucose over 126 mg/dL.
- Renal impairment.
- Liver dysfunction.
- Pregnancy.
- Known allergy to any study intervention components.
AI-Screening
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Trial Site Locations
Total: 32 locations
1
University of California Los Angeles (UCLA) - Mattel Children's Hospital
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado, United States, 3433325
Not Yet Recruiting
3
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, United States, 19803
Not Yet Recruiting
4
Children's Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Not Yet Recruiting
5
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
6
Atlantic Health System
Morristown, New Jersey, United States, 07901
Not Yet Recruiting
7
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Not Yet Recruiting
8
The State University of New York (SUNY) School of Medicine and Biomedical Sciences
Buffalo, New York, United States, 13210
Not Yet Recruiting
9
Hassenfeld Children's Hospital at NYU Langone
New York, New York, United States, 10016
Not Yet Recruiting
10
Dell Children's Medical Group
Austin, Texas, United States, 78723
Not Yet Recruiting
11
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Not Yet Recruiting
12
The University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
13
Centre Hospitalier Universitaire d'Angers
Angers, France
Not Yet Recruiting
14
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
Not Yet Recruiting
15
Chu de Lyon - Hopital Femme Mere Enfant
Lyon, France
Not Yet Recruiting
16
CHU Hôpital de la Timone
Marseille, France
Not Yet Recruiting
17
Hôpital Armand-Trousseau
Paris, France
Not Yet Recruiting
18
Hôpital Necker - Enfants Malades
Paris, France
Not Yet Recruiting
19
Jehangir Hospital
Maheshra, India
Not Yet Recruiting
20
Apollo Hospitals Enterprise Limited
Navi Mumbai, India
Not Yet Recruiting
21
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi, India
Not Yet Recruiting
22
Sir Ganga Ram Hospital
New Delhi, India
Not Yet Recruiting
23
Schneider Children Medical Center- the institute of Endocrinology and Diabetes
Petah Tikva, Israel, Israel, 4920235
Actively Recruiting
24
Shaare Zedek Medical Center
Jerusalem, Israe, Israel, 9103102
Not Yet Recruiting
25
Soroka hospital
Bear Sheva, Israel
Not Yet Recruiting
26
Sheba Medical Center
Ramat Gan, Israel
Not Yet Recruiting
27
Assaf Harofe Medical Center
Rishon LeZiyyon, Israel
Not Yet Recruiting
28
Dana-Duek children's hospital
Tel Aviv, Israel
Not Yet Recruiting
29
Osaka Women's and Children's Hospital
Izumi-Shi, Japan
Not Yet Recruiting
30
Nara Prefecture General Medical Center
Nara, Japan
Not Yet Recruiting
31
Osaka City General Hospital
Osaka, Japan
Not Yet Recruiting
32
National Center for Child Health and Development
Setagaya-Ku, Japan
Not Yet Recruiting
Research Team
M
Moshe Phillip, Professor
CONTACT
A
Alona Hamou, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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