A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

NCT ID: NCT05330325

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2027-10-29

Brief Summary

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The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.

Detailed Description

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Conditions

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SGA, Turner Syndrome, Noonan Syndrome, ISS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somapacitan

Participants will receive Somapacitan for 273 weeks

Group Type EXPERIMENTAL

Somapacitan

Intervention Type DRUG

Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

Norditropin®

Participants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)

Group Type ACTIVE_COMPARATOR

Norditropin®

Intervention Type DRUG

Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Interventions

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Somapacitan

Somapacitan will be administered subcutaneously (s.c.) once weekly using PDS290 pen-injector.

Intervention Type DRUG

Norditropin®

Norditropin® will be administered s.c. once daily using FlexPro® pen-injector.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Informed consent of parent or legally acceptable representative of participant and child assent, as age appropriate must be obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. No prior exposure to growth promoting therapy, including but not limited to growth hormone, IGF-I and ghrelin analogues.

Applicable to children with SGA:
3. Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
4. Prepubertal children:

1. Boys:

* Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
* Testis volume below 4 mL
2. Girls:

* Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
* Tanner stage 1 for breast development: No palpable glandular breast tissue)
5. Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
6. Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and sex according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
7. Body Mass Index below the 95th percentile according to Centers for Disease Control and Prevention, Body Mass Index-for-age growth charts.

Applicable to girls with TS:
8. Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis.\*
9. Prepubertal girls:

* Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
* Tanner stage 1 for breast development: No palpable glandular breast tissue)
10. Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
11. Historical height measured 6-18 months prior to screening.
12. Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.

Applicable to children with NS:
13. Clinical diagnosis of NS according to van der Burgt score list
14. Prepubertal children:

1. Boys:

* Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
* Testis volume below 4 mL
2. Girls:

* Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
* Tanner stage 1 for breast development: No palpable glandular breast tissue)
15. Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
16. Historical height measured 6-18 months prior to screening.
17. Thyroid hormone replacement therapy should be adequate and stable for at least 90 days prior to randomization, if applicable.

Applicable to children with ISS:
18. Prepubertal children:

1. Boys:

* Age above or equal to 2 years and 26 weeks and below 11.0 years at screening.
* Testis volume below 4 mL
2. Girls:

* Age above or equal to 2 years and 26 weeks and below 10.0 years at screening.
* Tanner stage 1 for breast development: No palpable glandular breast tissue)
19. Bone age:

1. Boys:

* Bone age below or equal to 12 years.
* Bone age not delayed or advanced more than 2 years compared to chronological age.
2. Girls:

* Bone age below or equal to 11 years.
* Bone age not delayed or advanced more than 2 years compared to chronological age.
20. Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
21. Historical height measured 6-18 months prior to screening.
22. One normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening or if such a test is not available for children with ISS, a test should be performed as part of the screening assessments and the result must be available prior to randomization.

* If a 30-cell count is not available for patients with TS, a test should be done, and results must be available prior to randomization.

Exclusion Criteria

1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Previous randomization into same sub-study in this study.
3. Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
4. Children with suspected or confirmed growth hormone deficiency according to local practice.
5. laboratory of

1. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
2. HbA1c above or equal to 6.5%.
6. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
7. Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/day of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.
8. Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
9. Diagnosis of attention deficit hyperactivity disorder (ADHD).
10. History or known presence of any malignancy, intracranial tumour, or intracranial cyst.
11. History or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
12. Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol.
13. The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator.
14. Current treatment with sex hormones or aromatase inhibitors.
15. Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, such as, but not limited to:

1. Known family history of skeletal dysplasia.
2. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
3. Any other disorder/condition that can cause short stature such as, but not limited to, psychosocial deprivation, nutritional disorders, chronic systemic illness and chronic renal disease.

Applicable to children with SGA:

1. TS (including mosaicism).
2. NS.
3. Hormonal deficiencies.
4. Children who are small due to malnutrition defined as -2 standard deviations according to standards. 0¬-5 years: weight for height on World Health Organization Multicentre Growth Reference Study 2006. Above 5 years: World Health Organization 2007 Body Mass Index.
5. Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.

Applicable to children with TS:

1. NS.
2. Mosaicism below 10%.
3. TS with Y-chromosome mosaicism where gonadectomy has not been performed.
4. NYHA class II or above or requiring medication for any heart condition.
5. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.

Applicable to children with NS:

1. TS (including mosaicism).
2. Noonan-related disorders: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome. Molecular genetic panel testing results must be available prior to randomisation to exclude these.
3. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.

Applicable to children with ISS:

1. TS (including mosaicism).
2. NS.
3. Hormonal deficiencies.
4. Born small for gestational age (defined as birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
5. Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Univ of AL at Birmingham_BRM

Birmingham, Alabama, United States

Site Status

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States

Site Status

Sutter Valley Med Fdt Ped Endo

Sacramento, California, United States

Site Status

Rady Childrens Hosp San Diego

San Diego, California, United States

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Children's Hospital Colorado

Aurora, Colorado, United States

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Rocky Mt Ped and Endo

Centennial, Colorado, United States

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Ped Endo Assoc PC-G.V

Greenwood Village, Colorado, United States

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Nemours/AI duPont Hosp-Chld

Wilmington, Delaware, United States

Site Status

Childrens National Medical Ctr

Washington D.C., District of Columbia, United States

Site Status

Nemours Chld Clnc Jacksonville

Jacksonville, Florida, United States

Site Status

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Site Status

St. Luke's Children's Endo

Boise, Idaho, United States

Site Status

Rocky Mt Clin Res, LLC

Idaho Falls, Idaho, United States

Site Status

Riley Hosp for Child-Indiana U

Indianapolis, Indiana, United States

Site Status

University OF Iowa

Iowa City, Iowa, United States

Site Status

UMass Medical School

Worcester, Massachusetts, United States

Site Status

Univ of Minnesota M.C.H.

Minneapolis, Minnesota, United States

Site Status

Children's Minnesota

Saint Paul, Minnesota, United States

Site Status

Univ of Mississippi Med Ctr

Jackson, Mississippi, United States

Site Status

The Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Goryeb Children's Hospital

Morristown, New Jersey, United States

Site Status

UBMD Peds-Div of Endo/Diabetes

Buffalo, New York, United States

Site Status

NYU Langone Hospital-LI

Garden City, New York, United States

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NYU Langone Hospital-LI

Mineola, New York, United States

Site Status

WakeMed Childn Endo-Dbt_Raleig

Raleigh, North Carolina, United States

Site Status

Akron Children's Hospital

Akron, Ohio, United States

Site Status

CCHMC_Cinc

Cincinnati, Ohio, United States

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Univ Oklahoma Sci Ctr OK City

Oklahoma City, Oklahoma, United States

Site Status

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

UT Southwestern Med Cntr

Dallas, Texas, United States

Site Status

Childrens' Hospital of Athens "Agia Sofia"

Goudi/Athens, , Greece

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P & A Kyriakou Childrens' Hospital

Goudi/Athens, , Greece

Site Status

General University of Patra - Paediatric Department

Pátrai, , Greece

Site Status

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, , Greece

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Cook Children's Medical Center

Fort Worth, Texas, United States

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Consano Clinical Research, LLC

Shavano Park, Texas, United States

Site Status

University Of Virginia Hospitl

Charlottesville, Virginia, United States

Site Status

MultiCare Inst for Res & Innov

Tacoma, Washington, United States

Site Status

Marshfield Clinic

Marshfield, Wisconsin, United States

Site Status

Kepler Universitätsklinikum GmbH - Med Campus IV (vorm.LFKK)

Linz, Upper Austria, Austria

Site Status

Krankenhaus der Stadt Dornbirn

Dornbirn, , Austria

Site Status

LKH St. Poelten, Kinder-und Jugendheilkunde

Sankt Pölten, , Austria

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Salzkammergut-Klinikum Vöcklabruck

Vöcklabruck, , Austria

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UZ Brussel

Brussels, , Belgium

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Cliniques Universitaires Saint-Luc - Serv. Pédiatrie

Brussels, , Belgium

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UZA - UZ Antwerpen - Kinderziekenhuis

Edegem, , Belgium

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UZ Leuven - Kindergeneeskunde

Leuven, , Belgium

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Centro de Diabetes Curitiba

Curitiba, Paraná, Brazil

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Santa Casa Sao Paulo

São Paulo, São Paulo, Brazil

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CPQuali Pesquisa Clínica Ltda

São Paulo, São Paulo, Brazil

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Centro de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

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UMHAT "Dr. Georgi Stranski" Pleven

Pleven, , Bulgaria

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UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics

Plovdiv, , Bulgaria

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SHATPD - Prof. Ivan Mitev EAD

Sofia, , Bulgaria

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MHAT "Sveta Marina"

Varna, , Bulgaria

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Children's Hosp-East Ontario

Ottawa, Ontario, Canada

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Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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Liuzhou Maternity and Child Healthcare Hospital-Child Healthcare

Liuchow, Guangxi, China

Site Status

Sanya Central Hospital (Hainan Third People's Hospital)-Pediatric

Sanya, Hainan, China

Site Status

Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism

Zhengzhou, Henan, China

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Wuhan Children Hospital-Endocrine Genetics and Metabolism

Wuhan, Hubei, China

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Wuhan Children Hospital

Wuhan, Hubei, China

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Tongji Hospital, Tongji Medical College of HUST-Pediatric

Wuhan, Hubei, China

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Hunan Children's Hospital-Child Health Center

Changsha, Hunan, China

Site Status

The First Bethune Hospital of Jilin University-Pediatric

Changchun, Jilin, China

Site Status

Shandong Provincial Hospital-Pediatric

Jinan, Shandong, China

Site Status

Shanghai Children's Hospital -Endocrine Genetics and Metabolism

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Children's Medical Center-Endocrine Genetics and Metabolism

Shanghai, Shanghai Municipality, China

Site Status

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Site Status

KBC "Sestre Milosrdnice"

Zagreb, , Croatia

Site Status

KBC Zagreb, Zavod za dječju endokrinologiju i dijabetes

Zagreb, , Croatia

Site Status

HUS Uusi lastensairaala

Helsinki, , Finland

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Centre Hospitalier Régional Universitaire d' Angers

Angers, , France

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Centre Hospitalier Universitaire D'Angers-2

Angers, , France

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Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

Bordeaux, , France

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CHU Pellegrin

Bordeaux, , France

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Ap-Hp-Hopital de Bicetre-1

Le Kremlin-Bicêtre, , France

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Hopital de Bicetre_Le Kremlin-Bicetre

Le Kremlin-Bicêtre, , France

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Assistance Publique Hopitaux de Marseille-Hopital de La Timone-2

Marseille, , France

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Hopital de La Timone

Marseille Cédex 05, , France

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Ap-Hp-Hopital Necker-2

Paris, , France

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Hôpital Necker

Paris, , France

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CHU de Toulouse

Toulouse, , France

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Hopital Des Enfants

Toulouse, , France

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Universitätsklinikum Bonn - Kinderklinik

Bonn, , Germany

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Universitätsklinikum Erlangen - Kinder- und Jugendklinik

Erlangen, , Germany

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Endokrinologikum Frankfurt

Frankfurt am Main, , Germany

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Klinik für Allgemeine Pädiatrie und Neonatologie

Homburg, , Germany

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Universitätsklinikum des Saarlandes - Pädiatrie und Neonatologie

Homburg, , Germany

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U.G.H. "Attikon", Pediatric Endocrinology Outpatient Clinic

Athens, , Greece

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"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, , Greece

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Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

Thessaloniki, , Greece

Site Status

Ippokrateio Gen Hosp of Thessaloniki, 1st Pediatric Clinic

Thessaloniki, , Greece

Site Status

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, , Greece

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Amrita Institute Of Medical Sciences & Research Centre

Kochi, Kerala, India

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Jehangir Clinical Development Centre

Pune, Maharashtra, India

Site Status

All India Institute of Medical Sciences

New Dehli, New Delhi, India

Site Status

Cork University Hospital

Cork, , Ireland

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CHI at Temple Street

Dublin, , Ireland

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CHI Crumlin Dept of Endocrinology

Dublin, , Ireland

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CHI Tallaght University Hospital

Dublin, , Ireland

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Soroka MC - Pediatric Endocrinology

Beersheba, , Israel

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Rambam MC - Department of Pediatrics A

Haifa, , Israel

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Schneider MC - Endrocrinology and Diabetes

Petah Tikva, , Israel

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Sheba MC - Pediatric endocrinology and adolescent diabetes clinics

Tel Litwinsky, , Israel

Site Status

Shamir MC - Pediatric and Adolescents Endocrinology unit

Ẕerifin, , Israel

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Ospedale San Raffaele S.r.l. - Unità Clinica Pediatria e neonatologia

Milan, Lombardy, Italy

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IRCCS Meyer Firenze

Florence, , Italy

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Ospedale Pediatrico Gaslini

Genova, , Italy

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Ospedale San Raffaele UO di Pediatria e UO di Neonatologia

Milan, , Italy

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Università degli Studi della Campania "L. Vanvitelli"

Napoli, , Italy

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Bambin Gesù

Roma, , Italy

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Ospedale Pediatrico Bambino Gesu

Roma, , Italy

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

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Fondazione Policlinico Universitario Agostino Gemelli IRCS

Rome, , Italy

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Fukuoka Children's Hospital_Endocrinology and Metabolism

Fukuoka-shi, Fukuoka, , Japan

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Fukuoka Children's Hospital

Fukuoka-shi, Fukuoka, , Japan

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Hyogo Prefectual Kobe Children's Hospital Dept. Metab & endo

Kobe-shi, Hyogo, , Japan

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Univ.HP, Kyoto Pref Univ of Medicine, Dept. of Pediatrics

Kyoto, , Japan

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Nara Prefecture General Medical Center

Nara-shi, Nara, , Japan

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Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, , Japan

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Okayama Medical Center_Cardiology

Okayama-shi, Okayama, , Japan

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Osaka City General Hospital, Pediatric Endocrinology and Me

Osaka, , Japan

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Osaka Women's and Children's Hospital

Osaka, , Japan

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Saitama Children's Medical Center, Endocrinorogy&Metabolism

Saitama-shi, Saitama, , Japan

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Hokkaido University Hospital, Pediatrics

Sapporo, Hokkaido, , Japan

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Hokkaido University Hospital_Pediatrics

Sapporo, Hokkaido, , Japan

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Shizuoka Children's Hospital, Department of Diabetes and metabolism

Shizuoka-shi, Shizuoka, , Japan

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Institute of Science Tokyo Hospital_Pediatrics

Tokyo, , Japan

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Institute of Science Tokyo Hospital

Tokyo, , Japan

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National Center for Child Health and Dev, Endo and Metabo

Tokyo, , Japan

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Keio University Hospital, Pediatrics

Tokyo, , Japan

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Fujita Health University Hospital, Pediatrics

Toyoake, Aichi, , Japan

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Children's Clinical University Hospital

Riga, , Latvia

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Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

Site Status

Hospital Universiti Sains Malaysia_Kota Bharu, Kelantan

Kota Bharu, Kelantan, Malaysia

Site Status

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status

University Malaya Medical Centre

Lembah Pantai, Kuala Lumpur, Malaysia

Site Status

University Technology MARA (UiTM) - Sg Buloh

Bandar Puncak Alam, Selangor, Malaysia

Site Status

University Technology MARA (UiTM) - Puncak Alam

Bandar Puncak Alam Selangor Darul Ehsan, , Malaysia

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Consultorio de Endocrinología y Pediatría

Puebla City, , Mexico

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Erasmus MC

Rotterdam, , Netherlands

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Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie

Rzeszów, Podkarpackie Voivodeship, Poland

Site Status

UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,

Gdansk, , Poland

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Górnośląskie Centrum Zdrowia Dziecka Szpital Kliniczny Nr 6

Katowice, , Poland

Site Status

Uniwer. Szpital Dzieciecy Klinika Endokry. Dzieci i Mlodzie

Krakow, , Poland

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Uniwersytecki Szptal Dziecięcy w Krakowie

Krakow, , Poland

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Klinika Endokrynologii i Chorób Metabolicznych

Lodz, , Poland

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SPSK nr 1 im Prof. T Sokolowskiego

Szczecin, , Poland

Site Status

Klinika Pediatrii SUM, SPSK nr 1 im. prof.S.Szyszko w Zabrzu_LOC#1

Zabrze, , Poland

Site Status

SPSK nr 1 im. prof.S.Szyszko w Zabrzu

Zabrze, , Poland

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Unidade Local de Saúde São José EPE- Hospital D. Estefânia

Lisbon, , Portugal

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Centro Hospitalar Lisboa Norte

Lisbon, , Portugal

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Unidade Local De Saude De Santa Maria E.P.E.

Lisbon, , Portugal

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Unidade Local de Saúde de Santo António, E.P.E

Porto, , Portugal

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Centro Hospitalar de Vila Nova de Gaia

Vila Nova de Gaia, , Portugal

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King Faisal Specialist Hospital & Research Centre, Riyadh

Riyadh, , Saudi Arabia

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National Guard Hospital

Riyadh, , Saudi Arabia

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University Clinical Centre Nis

Niš, RS, Serbia

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University Children's Hospital Tirsova

Belgrade, , Serbia

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Institute for Mother and Child Health Care of Serbia

Belgrade, , Serbia

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University Clinical Centre Kragujevac

Kragujevac, , Serbia

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University Clinical Centre Nis

Niš, , Serbia

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Institute for Health Care of Children and Adolescents

Novi Sad, , Serbia

Site Status

PeK - Dept. of Paediatric Endocrinology, Diabetes and Metabolism

Ljubljana, , Slovenia

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University Children's Hospital

Ljubljana, , Slovenia

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Department of Peadiatrics CHBAH

Johannesburg, Gauteng, South Africa

Site Status

Dr JC van Dyk's Rooms

Pretoria, Gauteng, South Africa

Site Status

Dr Y Ganie's site

Mayville, KwaZulu-Natal, South Africa

Site Status

Dr K Pillay's site

Westville, KwaZulu-Natal, South Africa

Site Status

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Site Status

Chungnam National University Sejong Hospital

Sejong-si, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Site Status

Hospital Madrid Montepríncipe

Boadilla del Monte, Madrid, Spain

Site Status

Hospital Sant Joan de Déu

Esplugues de Llobregat, , Spain

Site Status

Med. Kinder- und Poliklinik

Bern, , Switzerland

Site Status

Ramathibodi Hospital - Ped-Endo and Metabolism

Ratchathewi, Bangkok, Thailand

Site Status

Ramathibodi Hospital - Ped-Endo and Metabolism

Bangkok, Ratchathewi, Thailand

Site Status

King Chulalongkorn Memorial hospital-Ped-Endocrinology

Bangkok, , Thailand

Site Status

King Chulalongkorn Memorial hospital_Ped-Endocrinology

Bangkok, , Thailand

Site Status

Phramongkutklao Hospital_Ped-Endo_Pediatrics

Bangkok, , Thailand

Site Status

PMK - Paediatrics Endocrinology Centre

Bangkok, , Thailand

Site Status

Siriraj Hospital_Dept of Paediatrics

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology

Chiang Mai, , Thailand

Site Status

Srinagarind Hospital

Khon Kaen, , Thailand

Site Status

Addenbrooke's Hospital_Cambridge

Cambridge, , United Kingdom

Site Status

Hull Royal Infirmary

Hull, , United Kingdom

Site Status

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status

Evelina Children's Hospital - St Thomas'

London, , United Kingdom

Site Status

Evelina London Children's Hospital

London, , United Kingdom

Site Status

Royal Manchester Children's Hospital

Manchester, , United Kingdom

Site Status

St George's Hospital

Tooting, , United Kingdom

Site Status

St Georges Hospital

Tooting, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Belgium Brazil Bulgaria Canada China Croatia Finland France Germany Greece India Ireland Israel Italy Japan Latvia Lithuania Malaysia Mexico Netherlands Poland Portugal Saudi Arabia Serbia Slovenia South Africa South Korea Spain Switzerland Thailand United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-005607-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1270-0862

Identifier Type: OTHER

Identifier Source: secondary_id

NN8640-4467

Identifier Type: -

Identifier Source: org_study_id