A PHASE 3 OPEN-LABEL RANDOMIZED MULTICENTER 12 MONTHS EFFICACY AND SAFETY STUDY OF WEEKLY MOD-4023 COMPARED TO DAILY GENOTROPIN THERAPY IN PRE-PUBERTAL CHILDREN WITH GROWTH HORMONE DEFICIENCY

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Growth Hormone Deficiency
  • Age: Between 3 Year(s) - 11 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Willing and able to provide written informed consent of the parent or legal guardian of the participant and written assent from pediatric participants
    2. Confirmed diagnosis of GHD by 2 different GH provocation tests
    3. Bone age is not older than Chronological Age
    4. Has no prior exposure to any r-hGH therapy
    5. Impaired Height and Height Velocity
    6. Children with multiple hormonal deficiencies must be on stable replacement therapies

You may not be eligible for this study if the following are true:

    1. Children with prior history of leukemia, lymphoma, sarcoma or any other form of cancer
    2. History of radiation therapy or chemotherapy
    3. Malnourished children
    4. Children with psychosocial dwarfism
    5. Children born small for gestational age
    6. Any CS abnormality likely to affect growth or the ability to evaluate growth
    7. T2 and T1 diabetic patients
    8. Chromosomal abnormalities
    9. Concomitant administration of other treatments that may have an effect on growth
    10. Children requiring glucocorticoid therapy
    11. Major medical conditions and/or presence of contraindication to r-hGH treatment
    12. More than 1 closed epiphyses
    13. Known or suspected HIV-positive patient, or patient with advanced diseases such as AIDS or tuberculosis
    14. Drug, substance, or alcohol abuse
    15. Known hypersensitivity to the components of study medication
    16. Other causes of short stature
    17. Participant and/or parent/ legal guardian likely to be non-compliant to study conduct
    18. Participating in another study with investigational agent



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