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

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ClinicalTrials.gov Identifier: NCT04970654
Recruitment Status : Recruiting
First Posted : July 21, 2021
Last Update Posted : December 1, 2021
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.

The study includes a 52 week treatment period and a minimum of 30 days follow up period.


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 : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Efficacy and Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® in Chinese Children With Growth Hormone Deficiency
Actual Study Start Date : July 22, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023


Arm Intervention/treatment
Experimental: Somapacitan weekly
participants will receive once-weekly somapacitan for 52 weeks
Drug: somapacitan
Somapacitan (0.16 mg/kg/week) 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
Drug: Norditropin®
Norditropin® (0.034 mg/kg/day) 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 height Standard Deviation Score (SDS) [ Time Frame: from baseline (week 0) to week 52 ]
    Measured in scores (-10 to +10). Height SDS will be derived using Centre for Disease Control and Prevention (CDC) standards.

  2. Change in height Velocity Standard Deviation Score [ Time Frame: from baseline (week 0) to week 52 ]
    Measured in scores (-10 to +10). HV SDS will be derived using Prader standards as reference data.

  3. Change in bone age [ Time Frame: from Visit 1 to Week 52 ]
    Measured in years

  4. Change in fasting plasma glucose [ Time Frame: from baseline (week 0) to week 52 ]
    Measured in mmol/L.

  5. Change in glycated haemoglobin (HbA1c) [ Time Frame: from baseline (week 0) to week 52 ]
    Measured in percentage

  6. Change in IGF-I Standard Deviation Score [ Time Frame: From baseline (week 0) to week 52 ]
    Measured in scores (-10 to +10)

  7. Change in IGFBP-3 Standard Deviation Score [ Time Frame: From baseline (week 0) to week 52 ]
    Measured in scores (-10 to +10)



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.


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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:

  • Informed consent of parent or legally acceptable representative of participant and child assent, as age-appropriate must be obtained before any trial related activities
  • The parent or legally acceptable representative of the child must sign and date the Informed consent form (according to local requirements)
  • The child must sign and date child assent form or provide oral assent (if required according to local requirements)
  • Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than or equal to 11.0 years at the time of signing informed consent.
  • Testis volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than or equal to 10.0 years at the time of signing informed consent. 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 WHO International Somatropin 98/574 standard
  • If only one growth hormone stimulation test is available before screening, then confirmation of growth hormone deficiency by second and different growth hormone stimulation test must be done
  • For children with at least 2 additional pituitary hormone deficiencies (other than growth hormone deficiency) only one growth hormone stimulation test is needed
  • Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender according to Chinese general population standards at screening
  • Impaired height velocity defined as annualised height velocity at screening less than 7cm/year for subjects between 2.5 and 3 years old and less than 5 cm/year for subjects from 3 years and above calculated over a time span of minimum 3 months and maximum 18 months prior to screening according to Chinese guideline and expert consensus on children with short stature and GH therapy
  • No prior exposure to growth hormone therapy or IGF-I treatment
  • Bone age less than chronological age at screening
  • Body Mass Index more than 5th and less than 95th percentile, Body Mass Index-for-age growth charts according to Chinese general population standards.
  • IGF-I < -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory
  • No intracranial tumour confirmed by magnetic resonance imaging or computer tomography scan. An image or scan taken within 9 months prior to screening can be used as screening data if the medical evaluation and conclusion is available

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product(s) or related products.
  • Previous participation in this trial. Participation is defined as randomisation.
  • Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical trial before randomisation
  • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements:
  • Turner Syndrome (including mosaicisms)
  • Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors
  • Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
  • Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome or skeletal dysplasias
  • Family history of skeletal dysplasia
  • Children born small for gestational age (birth weight 10th percentile of the recommended gender-specific birth weight for gestational age according to national standards in China5
  • Children diagnosed with diabetes mellitus or screening values from central laboratory of

    1. fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or
    2. HbA1c more than or equal to 6.5 %
  • 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 greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
  • 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)
  • Diagnosis of attention deficit hyperactivity disorder
  • Prior history or presence of malignancy including intracranial tumours
  • Prior history or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B)
  • Any clinically significant abnormal laboratory screening tests, as judged by the study doctor
  • Any disorder which, in the opinion of the study doctor, might jeopardise Participant's safety or compliance with the protocol
  • The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the study doctor
  • Children with hypothyroidism and/or adrenal insufficiency not on adequate and stable replacement therapy for at least 90 days prior to randomisation.

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): NCT04970654


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

Locations
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China, Anhui
Novo Nordisk Investigational Site Not yet recruiting
Hefei, Anhui, China, 230601
China, Beijing
Novo Nordisk Investigational Site Not yet recruiting
Beijing, Beijing, China, 100020
Novo Nordisk Investigational Site Not yet recruiting
Beijing, Beijing, China, 100045
China, Guangdong
Novo Nordisk Investigational Site Recruiting
Guangzhou, Guangdong, China, 510080
China, Henan
Novo Nordisk Investigational Site Recruiting
Zhengzhou, Henan, China, 450018
China, Hubei
Novo Nordisk Investigational Site Recruiting
Wuhan, Hubei, China, 430030
China, Hunan
Novo Nordisk Investigational Site Not yet recruiting
Changsha, Hunan, China, 410007
Novo Nordisk Investigational Site Recruiting
Changsha, Hunan, China, 410011
Novo Nordisk Investigational Site Not yet recruiting
Shaoyang, Hunan, China, 422000
China, Jiangsu
Novo Nordisk Investigational Site Recruiting
Suzhou, Jiangsu, China, 215025
Novo Nordisk Investigational Site Recruiting
Wuxi, Jiangsu, China, 214023
China, Jiangxi
Novo Nordisk Investigational Site Recruiting
Nanchang, Jiangxi, China, 330006
Novo Nordisk Investigational Site Recruiting
Pingxiang, Jiangxi, China, 337055
China, Jilin
Novo Nordisk Investigational Site Recruiting
Changchun, Jilin, China, 130021
China, Shandong
Novo Nordisk Investigational Site Recruiting
Jinan, Shandong, China, 250021
Novo Nordisk Investigational Site Not yet recruiting
Linyi, Shandong, China, 276016
Novo Nordisk Investigational Site Recruiting
Qingdao, Shandong, China, 266043
China, Sichuan
Novo Nordisk Investigational Site Recruiting
Chengdu, Sichuan, China, 610000
China, Zhejiang
Novo Nordisk Investigational Site Recruiting
Hangzhou, Zhejiang, China, 310003
Novo Nordisk Investigational Site Recruiting
Jiaxing, Zhejiang, China, 314000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04970654    
Other Study ID Numbers: NN8640-4468
U1111-1250-7530 ( Other Identifier: World Health Organization )
2020-002974-28 ( Other Identifier: European Medicines Agency (EudraCT) )
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
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: http://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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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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