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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)

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 : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE January 18, 2019
First Posted Date  ICMJE January 22, 2019
Last Update Posted Date March 10, 2021
Actual Study Start Date  ICMJE May 20, 2019
Estimated Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2021)
  • Change in bone age [ Time Frame: From screening (week -2) to visit 7 (week 52) ]
    Measured in years.
  • Change in Height Standard Deviation Score [ Time Frame: From baseline (week 0) to visit 7 (week 52) ]
    Measured in scores (-10 to +10). Height SDS will be derived using Centre for Disease Control and Prevention (CDC) standards.
  • Change in height velocity standard deviation score (HV SDS) [ Time Frame: From baseline (week 0) to visit 7 (week 52) ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.
  • Change in fasting plasma glucose (FPG): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in mmol/L.
  • Change in FPG: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in mmol/L.
  • Change in FPG: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in mmol/L.
  • Change in FPG: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in mmol/L.
  • Change in homeostatic model assessment (HOMA): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage.
  • Change in HOMA: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage.
  • Change in HOMA: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage.
  • Change in HOMA: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage.
  • Change in glycated haemoglobin (HbA1c): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage
  • Change in HbA1c: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage
  • Change in HbA1c: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage
  • Change in HbA1c: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage
  • Change in insulin-like growth factor I (IGF-I) SDS: Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).
  • 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).
  • Change in IGFBP-3 SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).
  • Change in IGFBP-3 SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).
  • Change in IGFBP-3 SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2019)
  • Change in bone age: Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in years.
  • Change in bone age: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in years.
  • Change in bone age: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in years.
  • Change in bone age: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in years.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Change in fasting plasma glucose (FPG): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in mmol/L.
  • Change in FPG: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in mmol/L.
  • Change in FPG: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in mmol/L.
  • Change in FPG: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in mmol/L.
  • Change in homeostatic model assessment (HOMA): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage.
  • Change in HOMA: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage.
  • Change in HOMA: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage.
  • Change in HOMA: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage.
  • Change in glycated haemoglobin (HbA1c): Week 52 [ Time Frame: Week -2, Week 52 ]
    Measured in percentage
  • Change in HbA1c: Week 104 [ Time Frame: Week -2, Week 104 ]
    Measured in percentage
  • Change in HbA1c: Week 156 [ Time Frame: Week -2, Week 156 ]
    Measured in percentage
  • Change in HbA1c: Week 208 [ Time Frame: Week -2, Week 208 ]
    Measured in percentage
  • Change in insulin-like growth factor I (IGF-I) SDS: Week 52 [ Time Frame: Week 0, Week 52 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).
  • Change in IGF-I SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).
  • 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).
  • Change in IGFBP-3 SDS: Week 104 [ Time Frame: Week 0, Week 104 ]
    Measured in scores (-10 to +10).
  • Change in IGFBP-3 SDS: Week 156 [ Time Frame: Week 0, Week 156 ]
    Measured in scores (-10 to +10).
  • Change in IGFBP-3 SDS: Week 208 [ Time Frame: Week 0, Week 208 ]
    Measured in scores (-10 to +10).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE A Trial Comparing the Effect and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Children With Growth Hormone Deficiency
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Growth Hormone Deficiency in Children
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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).
    Intervention: Drug: Somapacitan
  • Active Comparator: Norditropin® daily
    Participants will receive Norditropin® daily for 52 weeks (main trial period).
    Intervention: Drug: Norditropin®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 22, 2021)
200
Original Estimated Enrollment  ICMJE
 (submitted: January 18, 2019)
188
Estimated Study Completion Date  ICMJE December 12, 2024
Estimated Primary Completion Date November 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Algeria,   Austria,   Canada,   Denmark,   Estonia,   France,   Germany,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Norway,   Poland,   Russian Federation,   Serbia,   Slovenia,   Spain,   Switzerland,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03811535
Other Study ID Numbers  ICMJE 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) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: https://www.novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP