Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811535
Recruitment Status : Active, not recruiting
First Posted : January 22, 2019
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 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
Actual Primary Completion Date : November 10, 2021
Estimated Study Completion Date : December 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 [ Time Frame: Week -2, Week 52 ]
    Measured in years.

  2. Change in Height Standard Deviation Score [ 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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  20. 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).

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

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

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 129 study locations
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Layout table for investigator information
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03811535    
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 22, 2019    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
 Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases