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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT02968004

Public ClinicalTrials.gov record NCT02968004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 21, 2026, 4:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Open-label, Randomized, Multicenter, 12 Months, Efficacy and Safety Study of Weekly MOD-4023 Compared to Daily Genotropin - Therapy in Pre-pubertal Children With Growth Hormone Deficiency

Study identification

NCT ID
NCT02968004
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
OPKO Health, Inc.
Industry
Enrollment
224 participants

Conditions and interventions

Interventions

  • MOD-4023 Drug
  • Somatropin Drug

Drug

Eligibility (public fields only)

Age range
3 Years to 11 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2016
Primary completion
Jul 31, 2019
Completion
Apr 30, 2024
Last update posted
Jul 19, 2025

2016 – 2024

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Children's Hospital of Orange County- Children's Clinic Orange California 92868
Children's Hospital- Colorado Aurora Colorado 80045
Rocky Mountain Pediatrics Centennial Colorado 80112
Nemours Children's Health System Jacksonville Florida 32207
University of Miami Medical Center Miami Florida 33136
St Luke's Children's Specialty Center Boise Idaho 83712
Children's Hospital of Iowa Iowa City Iowa 52242
Tufts Medical Center Boston Massachusetts 02111
University of Massachusettes Worcester Massachusetts 01655
University of Minnesota Minneapolis Minnesota 55454
The Diabetes & Obesity Clinical Specialist Las Vegas Nevada 89148
Goryeb Children's Hospital Morristown New Jersey 07962
Buffalo Children's Hospital Buffalo New York 14222
Albert Einstein College of Medicine at Yeshiva University Mineola New York 11501
Children's Hospital of Cincinnati / Cincinnati Center for Growth Disorders Cincinnati Ohio 45229
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
Cook Children's Medical Center Fort Worth Texas 76104
Mary Bridge Children's Hospital & Health Center Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 63 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02968004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 19, 2025 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02968004 live on ClinicalTrials.gov.

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