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

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Brief Title

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

Official Title

Safety and Dose Finding Study of Different MOD-4023 Dose Levels Compared to Daily R-human Growth Hormone (hGH) Therapy in Pre-pubertal Growth Hormone Deficient Children

Brief Summary

      Protocol CP-4-004-EXT is designed as a long-term, open-label extension using single patient
      use, multi-dose, disposable pre-filled pen.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Annual Height Velocity

Secondary Outcome

 Absolute IGF-I levels on day 4 after MOD-4023 dosing

Condition

Growth Hormone Deficiency (GHD)

Intervention

MOD-4023

Study Arms / Comparison Groups

 MOD-4023
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

48

Start Date

February 2013

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

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

        Exclusion Criteria:

          1. Children with past or present intracranial tumor growth as confirmed by an MRI scan
             (with contrast).

          2. History of radiation therapy or chemotherapy.

          3. Malnourished children defined as:

               1. Serum albumin below the lower limit of normal (LLN) according to the reference
                  ranges of central laboratory;

               2. Serum iron below the lower limit of normal (LLN) according to the reference
                  ranges of central laboratory;

               3. BMI < -2 Standard Deviation for age and sex;

          4. Children with psychosocial dwarfism.

          5. Children born small for gestational age (SGA - birth weight and/or birth length < -2
             SD for gestational age).

          6. Presence of anti-hGH antibodies at screening.

          7. 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.

          8. Patients with diabetes mellitus.

          9. Patients with impaired fasting sugar (based on WHO; fasting blood sugar >110 mg/dl or
             6.1 mmol/l) after repeated blood analysis.

         10. 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.

         11. Closed epiphyses.

         12. 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))

         13. 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.

         14. Major medical conditions and/or presence of contraindication to r-hGH treatment.

         15. Known or suspected HIV-positive patient, or patient with advanced diseases such as
             AIDS or tuberculosis.

         16. Drug, substance, or alcohol abuse.

         17. Known hypersensitivity to the components of study medication.

         18. Other causes of short stature such as coeliac disease, hypothyroidism and rickets.

         19. The patient and/or the parent/legal guardian are likely to be non-compliant in respect
             to study conduct.

         20. Participation in any other trial of an investigational agent within 30 days prior to
             Screening.
      

Gender

All

Ages

3 Years - 11 Years

Accepts Healthy Volunteers

No

Contacts

Zvi Zadik, MD, , 

Location Countries

Belarus

Location Countries

Belarus

Administrative Informations


NCT ID

NCT02500316

Organization ID

CP-4-004-extension

Secondary IDs

2011-004553-60

Responsible Party

Sponsor

Study Sponsor

OPKO Health, Inc.


Study Sponsor

Zvi Zadik, MD, Principal Investigator, Kaplan Medical Center, Israel


Verification Date

April 2022