NN8640-4245 - A dose-finding trial evaluating the effect and safety of once-weekly treatment of somapacitan compared to daily Norditropin in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older

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 - 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. Subjects are pre-pubertal children
        Boys
      • Age = 2 years and 26 weeks and <11.0 years at screening
      • Testes volume < 4ml
    3. Subjects are pre-pubertal children
        Girls
      • Age = 2 years and 26 weeks and <10.0 years at screening
      • Tanner stage 1 for breast development
    4. Subjects who are born small for gestational age
    5. Subjects with impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention.
    6. Subjects with impaired height velocity defined as annualised height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
    7. Subjects with no prior exposure to growth hormone therapy or IGF-I treatment
    8. Subjects who had gestational age at birth = 32 weeks.
    9. Subjects with body Mass Index <95th percentile according to Centers for Disease Control and Prevention, Body Mass Index-for-age growth charts.

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

    1. Subjects with known or suspected hypersensitivity to trial product(s) or related products.
    2. Subjects with previous participation in this trial
    3. Subjects receiving any investigational medicinal product within 3 months before screening or participation in another clinical trial at time of randomisation.
    4. Subjects with any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
    5. Subjects with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise
    6. Subjects diagnosed with diabetes mellitus
    7. Subjects currently have inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
    8. Subjects 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. Subjects with 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 diagnosed with attention deficit hyperactivity disorder
    11. Subjects have prior history or known presence of malignancy including intracranial tumours
    12. Prior history or known presence of active Hepatitis B or Hepatitis C
    13. Any disorder which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol.
    14. The subject or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the investigator.
    15. Children who are small due to malnutrition defined as -2 SD according to standards



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