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A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

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ClinicalTrials.gov Identifier: NCT03811535
Recruitment Status : Recruiting
First Posted : January 21, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The study compares 2 medicines for children who do not have enough hormone to grow: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Researchers will test to see how well somapacitan works. The study will also test if somapacitan is safe. Participants will either get somapacitan or Norditropin® - which treatment participants get, is decided by chance. Both participants and the study doctor will know which treatment participants get. The study will last for 4 years. Participants will attend 19 clinic visits and have 1 phone call with the study doctor.

Condition or disease Intervention/treatment Phase
Growth Hormone Deficiency in Children Drug: Somapacitan Drug: Norditropin® Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will receive either somapacitan once weekly or Norditropin® once daily for 52 weeks (main trial period). All participants completing the main trial period will receive somapacitan weekly for 3 years (extension trial period).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
Actual Study Start Date : May 20, 2019
Estimated Primary Completion Date : June 5, 2021
Estimated Study Completion Date : July 4, 2024


Arm Intervention/treatment
Experimental: Somapacitan weekly
Participants will receive somapacitan weekly for 52 weeks (main trial period). Participants completing the main trial period in both the treatment arms ('Somapacitan weekly' and 'Norditropin® daily') will receive somapacitan weekly for 3 years (extension trial period).
Drug: Somapacitan
Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.

Active Comparator: Norditropin® daily
Participants will receive Norditropin® daily for 52 weeks (main trial period).
Drug: Norditropin®
Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.




Primary Outcome Measures :
  1. Height velocity [ Time Frame: Week 0-52 ]
    Height velocity (HV) is measured in cm/year. HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).


Secondary Outcome Measures :
  1. Change in bone age: Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in years.

  2. Change in bone age: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in years.

  3. Change in bone age: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in years.

  4. Change in bone age: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in years.

  5. Change in height standard deviation score (SDS): Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10). Height SDS will be derived using Centre for Disease Control and Prevention (CDC) standards.

  6. Change in Height SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10). Height SDS will be derived using CDC standards.

  7. Change in Height SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10). Height SDS will be derived using CDC standards.

  8. Change in Height SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10). Height SDS will be derived using CDC standards.

  9. Change in height velocity standard deviation score (HV SDS): Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.

  10. Change in HV SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.

  11. Change in HV SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.

  12. Change in HV SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.

  13. Change in fasting plasma glucose (FPG): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in mmol/L.

  14. Change in FPG: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in mmol/L.

  15. Change in FPG: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in mmol/L.

  16. Change in FPG: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in mmol/L.

  17. Change in homeostatic model assessment (HOMA): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage.

  18. Change in HOMA: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage.

  19. Change in HOMA: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage.

  20. Change in HOMA: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage.

  21. Change in glycated haemoglobin (HbA1c): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage

  22. Change in HbA1c: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage

  23. Change in HbA1c: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage

  24. Change in HbA1c: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage

  25. Change in insulin-like growth factor I (IGF-I) SDS: Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10).

  26. Change in IGF-I SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).

  27. Change in IGF-I SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).

  28. Change in IGF-I SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).

  29. Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS: Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10).

  30. Change in IGFBP-3 SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).

  31. Change in IGFBP-3 SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).

  32. Change in IGFBP-3 SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue)
  • Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/ml using the World Health Organisation (WHO) International Somatropin 98/574 standard
  • Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
  • Impaired height velocity, defined as annualised height velocity below the 25th 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
  • Insulin-like Growth Factor-I (IGF-I) less than -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
  • No prior exposure to growth hormone therapy or IGF-I treatment

Exclusion Criteria:

  • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
  • Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening
  • 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
  • Diagnosis of attention deficit hyperactivity disorder
  • 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
  • Prior history or presence of malignancy including intracranial tumours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811535


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03811535     History of Changes
Other Study ID Numbers: NN8640-4263
U1111-1207-9691 ( Other Identifier: World Health Organization (WHO) )
2018-000231-27 ( Other Identifier: European Medicines Agency (EudraCT) )
JapicCTI-194773 ( Registry Identifier: JAPIC (Japan) )
First Posted: January 21, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: https://www.novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dwarfism, Pituitary
Dwarfism
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs