Last updated on November 2018

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


Brief description of study

This will be an open-label, randomized, multicenter, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.

Detailed Study Description

The study will consist of a 12 month, open-label, randomized, active controlled, parallel group study comparing the efficacy and safety of weekly MOD-4023 to daily growth hormone (GH), Genotropin. After 12 months, subjects will have the option to enter the long term open-label extension.

Clinical Study Identifier: NCT02968004

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Cindy Chin, MD

University of Arizona
Tucson, AZ United States

Ron Newfield, MD

Rady Children's Hospital
San Diego, CA United States

Megan Kelsey, MD

Children's Hospital- Colorado
Aurora, CO United States

Aristides Maniatis, MD

Rocky Mountain Pediatrics
Centennial, CO United States

Evan Graber, MD

Nemours/duPont Hospital for Children
Wilmington, DE United States

Nelly Mauras, MD

Nemours Children's Health System
Jacksonville, FL United States

Yong Bao, MD

University of Miami Medical Center
Miami, FL United States

Paul Desrosiers, MD

Arnold Palmer Hospital- Endocrine & Diabetes Center
Orlando, FL United States

Eric Felner, MD

CHOA Emory University
Atlanta, GA United States

Daniel Flynn, MD

St Luke's Children's Specialty Center
Boise, ID United States

Eva Tsalikian, MD

Children's Hospital of Iowa
Iowa City, IA United States

Robert Gensure, MD

Tufts Medical Center
Boston, MA United States

Bradley Miller, MD

University of Minnesota
Minneapolis, MN United States

Asheesh Dewan, MD

The Diabetes & Obesity Clinical Specialist
Las Vegas, NV United States

Steven Ghanny, MD

Hackensack University Medical Center
Hackensack, NJ United States

Barbara Cerame, MD

Goryeb Children's Hospital
Morristown, NJ United States

Ping Zhou, MD

Children's Hospital at Montefiore
Bronx, NY United States

Paul Saenger, MD

Albert Einstein College of Medicine at Yeshiva University
Mineola, NY United States

Robert Rapaport, MD

Icahn School of Medicine at Mount Sinai
New York, NY United States

Rolando Lozano

Central Ohio Pediatric Endocrinology/Diabetes
Columbus, OH United States

Oscar Escobar, MD

Children's Hospital of Pittsburgh
Pittsburgh, PA United States

Joel Steelman, MD

Cook Children's Medical Center
Fort Worth, TX United States

Patricia Fechner, MD

Seattle Children's Hospital
Seattle, WA United States

Gad Kletter, MD

Mary Bridge Children's Hospital & Health Center
Tacoma, WA United States

Cecilia Rudaz, MD

The Canberra Hospital
Garran, Australia

Patricia Crock, MD

John Hunter Children's Hospital
New Lambton Heights, Australia

Geoffrey Ambler, MD

Children's Hospital at Westmead
Westmead, Australia

George Werther, MD

The Royal Chldren's Hospital
Flemington, Australia

Catherine Choong, MD

PM Hospital for Children
Subiaco, Australia

Violeta Iotova, MD

MHAT Sveta Marina
Varna, Bulgaria

Andrea Hagg, MD

Alberta Diabetes Institute
Edmonton, AB Canada

Mariam Balakhadze, MD

Maritime Hospital JSC
Batumi, Georgia

Maia Rekhviashvili, MD

Vere XXI JSC
Tbilisi, Georgia

Ekaterine Kvaratskhelia, MD

David Metreveli Medical Center
Tbilisi, Georgia

Dirk Schnabel, MD

Charite Universitatsmedizin Berlin
Berlin, Germany

Klaus Mohnike, MD

Otto-von-Guericke-University
Magdeburg, Germany

Gerd Horneff, MD

Asklepios Kinderklinik Sankt Augustin
Sankt Augustin, Germany

Parag Shah, MD

Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, India

Mala Dharmalingam, MD

M.S. Ramamiah Medical College and Hospitals
Bangalore, India

Shaila Bhattacharyya, MD

Manipal Hospital
Bengaluru, India

Sunil Ambulkar, MD

Meditrina Institute of Medical Sciences
Nagpur, India

Jayashri Shembalkar, MD

Getwell Health & Research Institute
Nagpur, India

Varman Khadlikar, MD

Jehangir Clinical Development Centre
Pune, India

Vijay Warad, MD

Inamdar Multispecialty Hospital
Pune, India

Kumaravel Velayutham, MD

Apollo Specialty Hospitals
Madurai, India

Kirtikumar Dharmshibhai Modi, MD

Care Hospital
Hyderabad, India

Dinesh Pandey, MD

MV Hospital & Research Centre
Lucknow, India

Apurba Ghosh, MD

Institute of Child Health
Kolkata, India

Rajesh Khadgawat, MD

All India Institute of Medical Sciences
New Delhi, India

Archana Arya, MD

Sir Gangaram Hospital
New Delhi, India

Young-Jun Rhie, MD

Korea Universtiy Ansan Hospital
Ansan, Korea, Republic of

Eun-Young Yoo, MD

Bundang Cha Hospital
Seongnam, Korea, Republic of

Woo Yeong Chung, MD

Inje University Busan Paik Hospital
Busan, Korea, Republic of

Cheol Woo Ko, MD

KyungPook National University Hospital
Daegu, Korea, Republic of

Eun-Young Kim, MD

Chosun University Hospital
Gwangju, Korea, Republic of

Ho-Seong Kim, MD

Severance Hospital
Seoul, Korea, Republic of

Il Tae Hwang, MD

Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of

Jin Soon Hwang, MD

Ajou University Hospital
Suwon, Korea, Republic of

Paul Hofman, MD

The Liggins Institute
Grafton, New Zealand

Esko Wiltshire, MD

Wellington Children's Hospital
Newtown, New Zealand

Ben Wheeler, MD

Dunedin School of Medicine
Dunedin, New Zealand

Olgierd Pilecki, MD

Woj. Szpital Dzieciency im Brudzinskiego
Bydgoszcz, Poland

Michael Stalvey, MD

Children's of Alabama- University of Alabama, Birmingham
Birmingham, AL United States

Amit Bhangoo, MD

Children's Hospital of Orange County- Children's Clinic
Orange, CA United States

Leslie Soyka, MD

University of Massachusettes
Worcester, MA United States

Ilene Fennoy, MD

Columbia University Medical Center
New York, NY United States

Andrew Dauber, MD

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

Elisaveta Stefanova, MD

Specialized Hospital for Active Treatment of Children's Diseases
Sofia, Bulgaria

Elizabeth Cummings, MD

IWK Health Centre
Halifax, NS Canada

John Vandermeulen, MD

McMaster Children's Hospital
Hamilton, ON Canada

Jill Hamilton, MD

Sick Kids Hospital
Toronto, ON Canada

Joachim Woelffe, MD

Universitarsklinik Bonn
Bonn, Germany

Rama Walia, MD

Postgraduate Institute of Medical Education and Research
Chandigarh, India

Marianna Rachmiel, MD

Assaf Harofeh Medical Center
Be'er Ya'aqov, Israel

Agha Baba Lavie Khademi Floris, ...

Shaare Zedek Medical Center
Jerusalem, Israel

Phillip Moshe, MD

Scheider Children's Medical Center
Petach Tikva, Israel

Yael Lebenthal, MD

Sourasky Medical Center
Tel Aviv, Israel

Edgard Cervantes Trujano, MD

Centro de Investigacion Clinica Acelerada, SC
Mexico City, Mexico

Miguel Angel Guagnelli Martinez, MD

Health Pharma Professional Research SA de CV
Mexico City, Mexico

Margarita Barrientos, MD

Hospital Angeles de Puebla
Puebla, Mexico

Diana Rosa Gonzalez Fernandez, MD

Instituto de Investigaciones Aplicadas a la Neurociencia
Durango, Mexico

Luis Gonzalez-Mendoza, MD

Miami Children's Research Institute
Miami, FL United States

Angela Figueroa Sobrero, MD

Hospital Materno Infantil San Roque
Paraná, Argentina

Dmitry Raduk, MD

Health Institution- 2nd City Pediatric Hospital
Minsk, Belarus

Cheri Deal, MD

Centre de recherche du CHU Sainte-Justine
Montréal, QC Canada

Constantine Polychronakos, MD

McGill University Health Centre
Montréal, QC Canada

Maude Millette, MD

Centre de recherche du CHU de Quebec- Universite Laval
Québec, QC Canada

Paola Duran, MD

Fundacion Cardioinfantil
Bogotá, Colombia

Herman Yupanqui, MD

Dexa Diab
Bogotá, Colombia

Camila Cespedes, MD

Hospital San Ignacio
Bogotá, Colombia

Silvia Chahin, MD

Uniendo
Bogotá, Colombia

Nora Zuluaga, MD

Hospital San Vicente de Paul
Medellín, Colombia

Veronica Abad, MD

Hospital Pablo Tobon Uribe
Medellín, Colombia

Gerhard Binder, MD

Universitatsklinikum Tubingen
Tübingen, Germany

Evangelia Charmandari, MD

Aghia Sophia Children's Hospital
Athens, Greece

Elpis Vlachopapadoupoulou, MD

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

Yardena Tenenbaum Rakover, MD

Haemek Medical Center
Afula, Israel

Eli Hershkovitz, MD

Soroka Medical Center
Be'er Sheva, Israel

Alina German, MD

Bnei Zion Medical Center
Haifa, Israel

Orit Hamiel, MD

Tel Hashomer Medical Center
Ramat Gan, Israel

Recruitment Status: Closed


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