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Growth Hormone Analogue
Long-acting hGH for Human Growth Hormone Deficiency
Phase 2
Waitlist Available
Led By Zvi Zadik, MD
Research Sponsored by OPKO Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 years
Awards & highlights
Study Summary
This trial is for a long-term, open-label extension using a single patient, multi-dose, disposable pre-filled pen.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annual Height Velocity
Delta height SDS every 12 months
Secondary outcome measures
Absolute IGF-I levels on day 4 after MOD-4023 dosing
IGF-I SDS on day 4 after MOD-4023 dosing
Other outcome measures
IGFBP-3 levels on day 3 or 4 after MOD-4023 dosing
Side effects data
From 2020 Phase 3 trial • 44 Patients • NCT0387401350%
Nasopharyngitis
27%
Influenza
23%
Conjunctivitis
18%
Pharyngitis
14%
Injection site pain
14%
Pyrexia
14%
Eczema asteatotic
9%
Gastroenteritis
9%
Otitis media
9%
Traumatic fracture
5%
Craniopharyngioma
5%
Asthma
5%
Vomiting
5%
Erythema infectiosum
5%
Rhinitis
5%
Bronchitis
5%
Conjunctivitis allergic
100%
80%
60%
40%
20%
0%
Study treatment Arm
Genotropin Treatment Arm
MOD-4023 Treatment Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: MOD-4023Experimental Treatment1 Intervention
Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable pre-filled pen (PEN).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MOD-4023
2013
Completed Phase 3
~250
Find a Location
Who is running the clinical trial?
OPKO Health, Inc.Lead Sponsor
47 Previous Clinical Trials
5,402 Total Patients Enrolled
2 Trials studying Human Growth Hormone Deficiency
86 Patients Enrolled for Human Growth Hormone Deficiency
Zvi Zadik, MDPrincipal InvestigatorKaplan Medical Center, Israel
1 Previous Clinical Trials
56 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have diabetes.You have a medical condition or a reason why you cannot receive the r-hGH treatment.You were born smaller than normal for the number of weeks you were in the womb (small for gestational age).You have a history of substance or alcohol abuse.You are allergic to any of the ingredients in the study medication.You do not have any other medical conditions that could cause short stature, such as celiac disease, hypothyroidism, or rickets.You cannot have participated in any other research study with an experimental drug for at least 30 days before screening.
Research Study Groups:
This trial has the following groups:- Group 1: MOD-4023
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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