A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

PHASE3CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

May 20, 2019

Primary Completion Date

November 10, 2021

Study Completion Date

September 30, 2025

Conditions
Growth Hormone Deficiency in Children
Interventions
DRUG

Somapacitan

Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

DRUG

Norditropin®

Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.

Trial Locations (94)

1004

Children's Clinical University Hospital, Riga

1525

University Children's Hospital, Ljubljana

3010

Med. Kinder- und Poliklinik, Bern

3100

LKH St. Poelten, Kinder-und Jugendheilkunde, Sankt Pölten

8036

Med. Univ. Graz -Klinische Abteilung f. Allgemeine Pädiatrie, Graz

10330

King Chulalongkorn Memorial hospital-Ped-Endocrinology, Bangkok

10400

PMK - Paediatrics Endocrinology Centre, Bangkok

11000

University Children's Hospital Tirsova, Belgrade

11070

Institute for Mother and Child Health Care of Serbia, Belgrade

11501

NYU Langone Hospital-LI, Mineola

13385

Hopital de La Timone, Marseille Cédex 05

13620

Seoul National University Bundang Hospital, Gyeonggi-do

15224

UPMC Child Hosp-Pittsburgh, Pittsburgh

15706

Hospital Clínico de Santiago de Compostela, Santiago de Compostela

16000

CHU Bab El Oued Pediatrics Dept, Algiers

Endo and Diab Dept El Oued, Algiers

16499

Ajou University Hospital, Gyeonggi-do

19803

A.I. duPont Hospital for Children/Nemours, Wilmington

21000

Institute for Health Care of Children and Adolescents, Novi Sad

21010

Vinnytsia Regional Clinical Endocrinological Centre - Therapeutic department #2, Vinnytsia

25000

endocrino-diabetology department, Hospital IBN BADIS., Constantine

30318

Van Meter Pediatric Endo PC, Atlanta

31096

Rambam MC - Department of Pediatrics A, Haifa

33000

Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin, Bordeaux

33180

Pediatric Endocrine & Wellness Center, Aventura

35233

Univ of AL at Birmingham_BRM, Birmingham

41944

Kyungpook National University Hospital, Daegu

44281

Meir MC - Department of Paediatrics, Kfar Saba

45229

CCHMC_Cinc, Cincinnati

46202

Riley Hospital For Children, Indianapolis

47392

Inje University Busan Paik Hospital, Busan

49100

Centre Hospitalier Universitaire D'Angers-2, Angers

49202

Schneider MC - Endrocrinology and Diabetes, Petah Tikva

50139

IRCCS Meyer Firenze, Florence

52242

University OF Iowa, Iowa City

55102

Children's Minnesota, Saint Paul

55454

Univ of Minnesota M.C.H., Minneapolis

60596

Endokrinologikum Frankfurt, Frankfurt am Main

61093

Kharkiv Regional Children's Clinical Hospital - Endocrinological department, Kharkiv

64111

Children's Mercy Clinics, Kansas City

72076

Uniklinik Tübingen - Kinder- und Jugendmedizin, Tübingen

73104

Univ Oklahoma Sci Ctr OK City, Oklahoma City

75015

Ap-Hp-Hopital Necker-2, Paris

76104

Cook Children's Medical Center, Fort Worth

78723

Dell Children's Medical Center, Austin

80112

Rocky Mt Ped and Endo, Centennial

89113

The Docs, Las Vegas

90027

Children's Hospital Los Angeles - Endocrinology, Los Angeles

92868

Children's Hosp Of Orange, Orange

94270

Ap-Hp-Hopital de Bicetre-1, Le Kremlin-Bicêtre

94275

Hopital de Bicetre_Le Kremlin-Bicetre, Le Kremlin-Bicêtre

95821

Sutter Valley Med Fdt Ped Endo, Sacramento

98405

MultiCare Inst for Res & Innov, Tacoma

110029

All India Institute of Medical Sciences, New Dehli

119435

Setchenov First Moscow State Medical University, Moscow

125373

RMAPE, Moscow

191144

SPSBHI City Children out-patient clinic #44, Saint Petersburg

344013

"FSBEI of Higher Education Rostov State Medical University", Rostov-on-Don

411001

Jehangir Clinical Development Centre, Pune

426009

Republic Children's Hospital of Ministry of Health of Udmurt, Izhevsk

443079

Samara Regional Children Clinical Hospital n.a. N.N. Ivanova, Samara

630048

Children's clinical city hospital #1, Novosibirsk

634050

Siberian State Medical University, Tomsk

682041

Amrita Institute Of Medical Sciences & Research Centre, Kochi

7033001

Shamir MC - Cardio and Pedi, Ẕerifin

80111-2803

Ped Endo Assoc PC-G.V, Greenwood Village

07962

Goryeb Children's Hospital, Morristown

A 5020

LKH Salzburg- Univ. Klinik f. Kinder- und Jugendheilkunde, Salzburg

T6G 2B7

Stollery Children's Hospital, Edmonton

00165

Ospedale Pediatrico Bambino Gesu, Roma

813-0017

Fukuoka Children's Hospital_Endocrinology and Metabolism, Fukuoka-shi, Fukuoka

720-8520

National Hospital Organization FUKUYAMA MEDICAL CENTER, Fukuyama-shi, Hiroshima

721-8511

Fukuyama City Hospital_Department of Pediatrics, Fukuyama-shi, Hiroshima

602-8566

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

311-4145

Ibaraki Children's Hospital_General Pediatrics, Mito, Ibaraki

630-8581

Nara Prefecture General Medical Center_ Nara-shi, Nara, Nara-shi, Nara

474-8710

Aichi Children's Health and Medical Center, Obu-shi, Aichi

701-1192

Okayama Medical Center_Cardiology, Okayama-shi, Okayama

534-0021

Osaka City General Hospital, Pediatric Endocrinology and Me, Osaka

594-1101

Osaka Women's and Children's Hospital, Osaka

431-3192

Hamamatsu Univ. School of Medicine Hospital, Pediatrics, Shizuoka

565-0871

Osaka University Hospital_Osaka_0, Suita-shi, Osaka

157 8535

National Center for Child Health and Dev, Endo and Metabo, Tokyo

158-0097

Tanaka Growth Clinic, Tokyo

04-730

Instytut ''Pomnik - Centrum Zdrowia Dziecka'', Warsaw

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08950

Hospital Sant Joan de Déu, Esplugues Llobregat(Barcelona)

04114

Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology, Kyiv

CB2 0QQ

Addenbrooke's Hospital_Cambridge, Cambridge

HU3 2JZ

Hull Royal Infirmary_Hull, Hull

L12 2AP

Alder Hey Children's Hospital, Liverpool

M13 9WL

Royal Manchester Children's Hospital, Manchester

SW17 0RE

St Georges Hospital, Tooting

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY