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

NCT02968004 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-07-20

Study results available
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Summary

This is 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.

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.

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Tony Cruz · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2019-08-31
Completion
2024-05-31

Countries

  • United States
  • Argentina
  • Australia
  • Belarus
  • Bulgaria
  • Canada
  • Colombia
  • Georgia
  • Greece
  • India
  • Israel
  • Mexico
  • New Zealand
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968004 on ClinicalTrials.gov