Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

Completed · Phase 2

Conditions studied: Growth Hormone Deficiency (GHD)

In brief

Protocol CP-4-004-OLE (Open Label Extension) is designed as a long-term, open-label extension using single patient use, multi-dose, disposable pre-filled pen.

Key facts

Study ID: NCT02500316
Run by: OPKO Health, Inc.
People needed: 48
Starts: 2014-02-01
Expected to finish: 2023-11-01
Last updated by the study team: 2025-04-09

Who can join

Age: 3 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients who completed the first year of treatment in the main study are allowed to enter the (Long Term) Open Label Extension (OLE) study.

You may not qualify if…

Children with past or present intracranial tumor growth as confirmed by an MRI scan (with contrast).
History of radiation therapy or chemotherapy.
Malnourished children defined as:
Serum albumin below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
Serum iron below the lower limit of normal (LLN) according to the reference ranges of central laboratory;
BMI < -2 Standard Deviation for age and sex;
Children with psychosocial dwarfism.
Children born small for gestational age (SGA - birth weight and/or birth length < -2 SD for gestational age).
Presence of anti-hGH antibodies at screening.
Any clinically significant abnormality likely to affect growth or the ability to evaluate growth, such as, but not limited to, chronic diseases like renal insufficiency, spinal cord irradiation, etc.
Patients with diabetes mellitus.
Patients with impaired fasting sugar (based on WHO; fasting blood sugar >110 mg/dl or 6.1 mmol/l) after repeated blood analysis.
Chromosomal abnormalities and medical "syndromes" (Turner's syndrome, Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, Russell-Silver Syndrome, short stature homeobox-containing gene (SHOX) mutations/deletions and skeletal dysplasias), with the exception of septo-optic dysplasia.
Closed epiphyses.
Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids and methylphenidate for attention deficit hyperactivity disorder (ADHD), with the exception of hormone replacement therapies (thyroxine, hydrocortisone, desmopressin (DDAVP))
Children requiring glucocorticoid therapy (e.g. asthma) who are taking a dose of greater than 400 µg/d of inhaled budesonide or equivalents for longer than 1 month during a calendar year.
Major medical conditions and/or presence of contraindication to r-hGH treatment.
Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis.
Drug, substance, or alcohol abuse.
Known hypersensitivity to the components of study medication.
Other causes of short stature such as coeliac disease, hypothyroidism and rickets.
The patient and/or the parent/legal guardian are likely to be non-compliant in respect to study conduct.
Participation in any other trial of an investigational agent within 30 days prior to Screening.

Where it is running

Nemours Children's Clinic — Jacksonville, Florida, United States
2DKB — Minsk, Belarus
Children's Hospital "P. A. Kyriakou" — Athens, Greece
Buda Children's Hospital — Budapest, Hungary
Endocrinology Scientific Centre, Institute of Child Endocrinology — Moscow, Russia
Russian Medical Academy of Postgraduate Education — Moscow, Russia
SPGPMA — Saint Petersburg, Russia
SamGMU — Samara, Russia
SBEIHPE — Ufa, Russia
Donetsk Regional Children Clinical Hospital — Donetsk, Ukraine
Institute of Endocrinology — Kiev, Ukraine
Ukrainian Scientific Center of Endocrine Surgery Moh of Ukraine — Kiev, Ukraine
Odessa Regional Children'S Clinical Hospital — Odesa, Ukraine

Full record on ClinicalTrials.gov

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