A trial comparing the effect and safety of once weekly dosing of somapacitan with daily Norditropin in 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 2 years - 11 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Informed consent of parent or legally acceptable representative of subject and child assent, as age-appropriate must be obtained before any trial-related activities
    2. Prepubertal children with confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation
    3. Subjects have impaired height
    4. No prior exposure to growth hormone therapy or IGF-I treatment
    5. Bone age less than chronological age at screening
    6. Body Mass Index >5th and <95th percentile according to Center for Disease Control and Prevention16, Body Mass Index-for-age growth charts
    7. No intracranial tumour confirmed by magnetic resonance imaging or computer tomography scan

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

    1. Children with known or suspected hypersensitivity to trial product(s) or related products
    2. Children who had previous participated in this trial.
    3. Children who received any investigational medicinal product within 3 months before screening or participation in another clinical trial at time of randomisation
    4. Children with any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
    5. Children born small for gestational age
    6. Children diagnosed with diabetes mellitus or screening values from laboratory results as per protocol
    7. Children with current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
    8. Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
    9. Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD)
    10. Subjects have diagnosis of attention deficit hyperactivity disorder
    11. Subjects with prior history or presence of malignancy including intracranial tumours
    12. Subjects with prior history or known presence of active Hepatitis B or Hepatitis C
    13. Subjects with any disorder which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
    14. Subjects or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the investigator.

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