Last updated on February 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.

Clinical Study Identifier: NCT02968004

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Cindy Chin, MD

University of Arizona
Tucson, AZ United States
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Ron Newfield, MD

Rady Children's Hospital
San Diego, CA United States
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Megan Kelsey, MD

Children's Hospital- Colorado
Aurora, CO United States
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Aristides Maniatis, MD

Rocky Mountain Pediatrics
Centennial, CO United States
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Evan Graber, MD

Nemours/duPont Hospital for Children
Wilmington, DE United States
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Nelly Mauras, MD

Nemours Children's Health System
Jacksonville, FL United States
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Yong Bao, MD

University of Miami Medical Center
Miami, FL United States
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Paul Desrosiers, MD

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

CHOA Emory University
Atlanta, GA United States
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Daniel Flynn, MD

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

Children's Hospital of Iowa
Iowa City, IA United States
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Robert Gensure, MD

Tufts Medical Center
Boston, MA United States
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Bradley Miller, MD

University of Minnesota
Minneapolis, MN United States
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Asheesh Dewan, MD

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

Hackensack University Medical Center
Hackensack, NJ United States
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Barbara Cerame, MD

Goryeb Children's Hospital
Morristown, NJ United States
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Ping Zhou, MD

Children's Hospital at Montefiore
Bronx, NY United States
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Paul Saenger, MD

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

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

Cincinnati Center for Growth Disorders
Cincinnati, OH United States
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Rolando Lozano

Central Ohio Pediatric Endocrinology/Diabetes
Columbus, OH United States
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Oscar Escobar, MD

Children's Hospital of Pittsburgh
Pittsburgh, PA United States
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Joel Steelman, MD

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

Seattle Children's Hospital
Seattle, WA United States
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Gad Kletter, MD

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

The Canberra Hospital
Garran, Australia
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Patricia Crock, MD

John Hunter Children's Hospital
New Lambton Heights, Australia
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Geoffrey Ambler, MD

Children's Hospital at Westmead
Westmead, Australia
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George Werther, MD

The Royal Chldren's Hospital
Flemington, Australia
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Catherine Choong, MD

PM Hospital for Children
Subiaco, Australia
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Violeta Iotova, MD

MHAT Sveta Marina
Varna, Bulgaria
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Andrea Hagg, MD

Alberta Diabetes Institute
Edmonton, AB Canada
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Cheri Deal, MD

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

McGill University Health Centre
Montréal, QC Canada
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Maude Millette, MD

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

Maritime Hospital JSC
Batumi, Georgia
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Maia Rekhviashvili, MD

Vere XXI JSC
Tbilisi, Georgia
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Ekaterine Kvaratskhelia, MD

David Metreveli Medical Center
Tbilisi, Georgia
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Dirk Schnabel, MD

Charite Universitatsmedizin Berlin
Berlin, Germany
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Klaus Mohnike, MD

Otto-von-Guericke-University
Magdeburg, Germany
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Gerd Horneff, MD

Asklepios Kinderklinik Sankt Augustin
Sankt Augustin, Germany
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Gerhard Binder, MD

Universitatsklinikum Tubingen
Tübingen, Germany
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Parag Shah, MD

Dr. Jivraj Mehta Smarak Health Foundation
Ahmedabad, India
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Mala Dharmalingam, MD

M.S. Ramamiah Medical College and Hospitals
Bangalore, India
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Shaila Bhattacharyya, MD

Manipal Hospital
Bengaluru, India
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Sunil Ambulkar, MD

Meditrina Institute of Medical Sciences
Nagpur, India
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Jayashri Shembalkar, MD

Getwell Health & Research Institute
Nagpur, India
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Varman Khadlikar, MD

Jehangir Clinical Development Centre
Pune, India
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Vijay Warad, MD

Inamdar Multispecialty Hospital
Pune, India
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Kumaravel Velayutham, MD

Apollo Specialty Hospitals
Madurai, India
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Kirtikumar Dharmshibhai Modi, MD

Care Hospital
Hyderabad, India
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Dinesh Pandey, MD

MV Hospital & Research Centre
Lucknow, India
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Apurba Ghosh, MD

Institute of Child Health
Kolkata, India
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Rajesh Khadgawat, MD

All India Institute of Medical Sciences
New Delhi, India
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Archana Arya, MD

Sir Gangaram Hospital
New Delhi, India
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Young-Jun Rhie, MD

Korea Universtiy Ansan Hospital
Ansan, Korea, Republic of
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Eun-Young Yoo, MD

Bundang Cha Hospital
Seongnam, Korea, Republic of
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Woo Yeong Chung, MD

Inje University Busan Paik Hospital
Busan, Korea, Republic of
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Cheol Woo Ko, MD

KyungPook National University Hospital
Daegu, Korea, Republic of
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Eun-Young Kim, MD

Chosun University Hospital
Gwangju, Korea, Republic of
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Ho-Seong Kim, MD

Severance Hospital
Seoul, Korea, Republic of
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Il Tae Hwang, MD

Hallym University Kangdong Sacred Heart Hospital
Seoul, Korea, Republic of
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Jin Soon Hwang, MD

Ajou University Hospital
Suwon, Korea, Republic of
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Paul Hofman, MD

The Liggins Institute
Grafton, New Zealand
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Esko Wiltshire, MD

Wellington Children's Hospital
Newtown, New Zealand
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Ben Wheeler, MD

Dunedin School of Medicine
Dunedin, New Zealand
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Olgierd Pilecki, MD

Woj. Szpital Dzieciency im Brudzinskiego
Bydgoszcz, Poland
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