Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

PHASE3CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

August 31, 2019

Study Completion Date

May 31, 2024

Conditions
Pediatric Growth Hormone Deficiency
Interventions
DRUG

MOD-4023

Once weekly subcutaneous injection using pre-filled pen device.

DRUG

Somatropin

Once daily subcutaneous injection of Genotropin using pre-filled pen device.

Trial Locations (81)

114

Tri-Service General Hospital, Taipei

1023

The Liggins Institute, Grafton

2145

Children's Hospital at Westmead, Westmead

2305

John Hunter Children's Hospital, New Lambton Heights

3100

Hospital Materno Infantil San Roque, Paraná

5000

Hospital de Ninos de la Santisima Trinidad Cordoba, Córdoba

6008

PM Hospital for Children, Subiaco

6010

Maritime Hospital JSC, Batumi

6021

Wellington Children's Hospital, Newtown

9010

MHAT Sveta Marina, Varna

11217

Taipei Veterans General Hospital, Taipei

11501

Albert Einstein College of Medicine at Yeshiva University, Mineola

11527

Aghia Sophia Children's Hospital, Athens

General Children's Hospital of Athens P&A Kyriakou, Athens

13497

Bundang Cha Hospital, Seongnam-si

14222

Buffalo Children's Hospital, Buffalo

15224

Children's Hospital of Pittsburgh, Pittsburgh

15706

Parc Tauli, Sabadell

17007

Hospital Josep Trueta, Girona

21010

Vinnitsa Regional Clinical Highly Specialized Endocrinology Centre, Vinnitsa

31008

Hospital de Navarra, Pamplona

32207

Nemours Children's Health System, Jacksonville

33011

Hospital Universitario Central de Asturias, Oviedo

33136

University of Miami Medical Center, Miami

41944

KyungPook National University Hospital, Daegu

45229

Children's Hospital of Cincinnati / Cincinnati Center for Growth Disorders, Cincinnati

47392

Inje University Busan Paik Hospital, Busan

49202

Scheider Children's Medical Center, Petah Tikva

50009

Hospital Miguel Servet, Zaragoza

52242

Children's Hospital of Iowa, Iowa City

55454

University of Minnesota, Minneapolis

61453

Chosun University Hospital, Gwangju

65031

Odesa Regional Clinical Children's Hospital, Odesa

69063

Zaporizhzhya Regional Clinical Child Hospital, Zaporizhzhya

72190

Hospital Angeles de Puebla, Puebla City

76100

Kaplan Medical Center, Rehovot

76104

Cook Children's Medical Center, Fort Worth

80045

Children's Hospital- Colorado, Aurora

80112

Rocky Mountain Pediatrics, Centennial

83712

St Luke's Children's Specialty Center, Boise

84101

Soroka Medical Center, Beersheba

89148

The Diabetes & Obesity Clinical Specialist, Las Vegas

92868

Children's Hospital of Orange County- Children's Clinic, Orange

98405

Mary Bridge Children's Hospital & Health Center, Tacoma

110029

All India Institute of Medical Sciences, New Delhi

110060

Sir Gangaram Hospital, New Delhi

110221

Dexa Diab, Bogotá

Uniendo, Bogotá

117036

Endocrinology Scientific Center, Moscow

125373

Pediatric City Clinical Hospital/Russian Medical Academy of Continuous Education, Moscow

160012

Postgraduate Institute of Medical Education and Research, Chandigarh

194100

Saint Petersburg State Pediatric Medical University, Saint Petersburg

220020

Health Institution- 2nd City Pediatric Hospital, Minsk

394024

Voronezh State Medical University, Voronezh

411001

Jehangir Clinical Development Centre, Pune

440010

Meditrina Institute of Medical Sciences, Nagpur

440012

Getwell Health & Research Institute, Nagpur

500001

Care Hospital, Hyderabad

560017

Manipal Hospital, Bengaluru

1834111

Haemek Medical Center, Afula

3339509

Bnei Zion Medical Center, Haifa

5265601

Tel Hashomer Medical Center, Ramat Gan

6423906

Sourasky Medical Center, Tel Aviv

7030000

Assaf Harofeh Medical Center, Be’er Ya‘aqov

9103102

Shaare Zedek Medical Center, Jerusalem

02111

Tufts Medical Center, Boston

01655

University of Massachusettes, Worcester

07962

Goryeb Children's Hospital, Morristown

H3T 1C5

Centre de recherche du CHU Sainte-Justine, Montreal

050034

Hospital Pablo Tobon Uribe, Medellín

0108

Vere XXI JSC, Tbilisi

80-211

Uniwersyteckie Centrum Kliniczne in Gdansk, Gdansk

93-338

Centrum Zdrowia Matki Polki, Lodz

450008/450106

Bashkirian State Medical University, Ufa

420012/420138

Kazan State Medical Univeristy/Pediatric Republic Clinical Hospital, Kazan'

03722

Severance Hospital, Seoul

08950

Hospital Universitario de Santiago de Compostela, Santiago de Compostela

01021

Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine, Kyiv

04114

Institute of Endocrinology and Metabolism/VP Komisarenko of Academy of Medical Science of Ukraine, Kyiv

G514TF

Royal Hospital for Children, Glasgow

SW17 OQT

St. George's University Hospital, London

All Listed Sponsors
lead

OPKO Health, Inc.

INDUSTRY

NCT02968004 - Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | Biotech Hunter | Biotech Hunter