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A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

NCT01909479 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2022-08-12

Study results available
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Summary

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

Conditions

  • Adult Growth Hormone Deficiency

Interventions

DRUG

MOD-4023

Individualized once weekly dose of MOD-4023

OTHER

Placebo

Once weekly administration of placebo

Sponsors & Collaborators

  • OPKO Health, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-08-31
Completion
2018-08-31

Countries

  • Israel

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 NCT01909479 on ClinicalTrials.gov