Phase
Condition
Growth Hormone Deficiencies/abnormalities
Treatment
somapacitan
Norditropin®
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Informed consent of parent or legally acceptable representative of participant andchild assent, as age-appropriate must be obtained before any trial relatedactivities
The parent or legally acceptable representative of the child must sign and date theInformed consent form (according to local requirements)
The child must sign and date child assent form or provide oral assent (if requiredaccording to local requirements)
Prepubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks andless 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 26weeks 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 growthhormone stimulation tests performed within 12 months prior to randomisation, definedas a peak growth hormone level of less than or equal to 10.0 ng/ml using the WHOInternational Somatropin 98/574 standard
If only one growth hormone stimulation test is available before screening, thenconfirmation of growth hormone deficiency by second and different growth hormonestimulation test must be done
For children with at least 2 additional pituitary hormone deficiencies (other thangrowth hormone deficiency) only one growth hormone stimulation test is needed
Impaired height defined as at least 2.0 standard deviations below the mean heightfor chronological age and gender according to Chinese general population standardsat screening
Impaired height velocity defined as annualised height velocity at screening lessthan 7cm/year for subjects between 2.5 and 3 years old and less than 5 cm/year forsubjects from 3 years and above calculated over a time span of minimum 3 months andmaximum 18 months prior to screening according to Chinese guideline and expertconsensus 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-agegrowth charts according to Chinese general population standards.
IGF-I < -1.0 SDS at screening, compared to age and gender normalized range measuredat central laboratory
No intracranial tumour confirmed by magnetic resonance imaging or computertomography scan. An image or scan taken within 9 months prior to screening can beused as screening data if the medical evaluation and conclusion is available
Exclusion
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 orparticipation in another clinical trial before randomisation
Any known or suspected clinically significant abnormality likely to affect growth orthe 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, kyphosisand spina bifida variants
Congenital abnormalities (causing skeletal abnormalities), including but not limitedto Russell-Silver Syndrome or skeletal dysplasias
Family history of skeletal dysplasia
Children born small for gestational age (birth weight 10th percentile of therecommended gender-specific birth weight for gestational age according to nationalstandards in China5
Children diagnosed with diabetes mellitus or screening values from centrallaboratory of
fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or
HbA1c more than or equal to 6.5 %
Current inflammatory diseases requiring systemic corticosteroid treatment for longerthan 2 consecutive weeks within the last 3 months prior to screening
Children requiring inhaled glucocorticoid therapy at a dose greater than 400 µg/dayof inhaled budesonide or equivalents for longer than 4 consecutive weeks within thelast 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 deficithyperactivity 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 tothis exclusion criterion is the presence of antibodies due to vaccination againstHepatitis B)
Any clinically significant abnormal laboratory screening tests, as judged by thestudy doctor
Any disorder which, in the opinion of the study doctor, might jeopardiseParticipant's safety or compliance with the protocol
The participant or the parent/legally acceptable representative is likely to benon-compliant in respect to trial conduct, as judged by the study doctor
Children with hypothyroidism and/or adrenal insufficiency not on adequate and stablereplacement therapy for at least 90 days prior to randomisation.
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Hefei, Anhui 230601
ChinaCompleted
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
The Second Hospital of Anhui Medical University
Hefei 1808722, Anhui 1818058 230601
ChinaSite Not Available
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing 100045
ChinaSite Not Available
Capital Institute of Paediatrics
Beijing, Beijing 100020
ChinaSite Not Available
Novo Nordisk Investigational Site
Beijing, Beijing 100045
ChinaSite Not Available
Beijing Children's Hospital, Capital Medical University
Beijing 1816670, Beijing Municipality 2038349 100045
ChinaSite Not Available
Novo Nordisk Investigational Site
Guangzhou, Guangdong 510080
ChinaCompleted
The First Affiliated Hospital , Sun Yat-sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou 1809858, Guangdong 1809935 510080
ChinaSite Not Available
Henan Children's Hospital
Zhengzhou, Henan 450018
ChinaSite Not Available
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan 450018
ChinaSite Not Available
Novo Nordisk Investigational Site
Zhengzhou, Henan 450018
ChinaActive - Recruiting
Henan Children's Hospital
Zhengzhou 1784658, Henan 1808520 450018
ChinaSite Not Available
Henan Children's Hospital Zhengzhou Children's Hospital-Endocrine Genetics and Metabolism
Zhengzhou 1784658, Henan 1808520 450018
ChinaSite Not Available
Novo Nordisk Investigational Site
Wuhan, Hubei 430030
ChinaCompleted
Tongji Hospital,Tongji Medical College of Huazhong University of Science &Technology
Wuhan, Hubei 430030
ChinaSite Not Available
Tongji Hospital, Tongji Medical College of HUST-Pediatric
Wuhan 1791247, Hubei 1806949 430030
ChinaSite Not Available
Hunan Children's Hospital
Changsha, Hunan 410007
ChinaSite Not Available
Novo Nordisk Investigational Site
Changsha, Hunan 410007
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaSite Not Available
Novo Nordisk Investigational Site
Shaoyang, Hunan 422000
ChinaCompleted
The First Affiliated Hospital of Shaoyang University
Shaoyang, Hunan 422001
ChinaSite Not Available
Hunan Children's Hospital
Changsha 1815577, Hunan 1806691 410007
ChinaSite Not Available
Hunan Children's Hospital-Child Health Center
Changsha 1815577, Hunan 1806691 410007
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha 1815577, Hunan 1806691 410011
ChinaSite Not Available
The First Affiliated Hospital of Shaoyang University-Pediatric
Shaoyang 1816920, Hunan 1806691 422001
ChinaSite Not Available
Children's Hospital of Soochow University
Suzhou, Jiangsu 215025
ChinaSite Not Available
Novo Nordisk Investigational Site
Suzhou, Jiangsu 215025
ChinaSite Not Available
Novo Nordisk Investigational Site
Wuxi, Jiangsu 214023
ChinaActive - Recruiting
Wuxi Children's Hospital
Wuxi, Jiangsu 214023
ChinaSite Not Available
Jiangxi Provincial Children's Hospital-Endocrine Genetics and Metabolism
Nanchang 7528770, Jiangsu 1806260 330006
ChinaSite Not Available
Children's Hospital of Soochow University
Suzhou 1886760, Jiangsu 1806260 215025
ChinaSite Not Available
Children's Hospital of Soochow University-Endocrine Genetics and Metabolism
Suzhou 1886760, Jiangsu 1806260 215025
ChinaSite Not Available
Wuxi Children's Hospital
Wuxi 1790923, Jiangsu 1806260 214023
ChinaSite Not Available
Wuxi Children's Hospital-Pediatric Endocrinology
Wuxi 1790923, Jiangsu 1806260 214023
ChinaSite Not Available
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi 330006
ChinaSite Not Available
Novo Nordisk Investigational Site
Nanchang, Jiangxi 330006
ChinaCompleted
Novo Nordisk Investigational Site
Pingxiang, Jiangxi 337055
ChinaActive - Recruiting
Pingxiang Maternal and Child Health Care Hospital
Pingxiang, Jiangxi 337055
ChinaSite Not Available
The First Hospital of Jiaxing
Jiaxing, Jiangxi 1806222 314001
ChinaSite Not Available
The First Hospital of Jiaxing-Pediatric
Jiaxing, Jiangxi 1806222 314001
ChinaSite Not Available
Pingxiang Maternal and Child Health Care Hospital
Pingxiang 1798654, Jiangxi 1806222 337055
ChinaSite Not Available
Pingxiang Maternal and Child Health Care Hospital-Child Health Care
Pingxiang 1798654, Jiangxi 1806222 337055
ChinaSite Not Available
Novo Nordisk Investigational Site
Changchun, Jilin 130021
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
The First Bethune Hospital of Jilin University-Pediatric
Changchun 2038180, Jilin 2036500 130021
ChinaSite Not Available
Novo Nordisk Investigational Site
Jinan, Shandong 250021
ChinaCompleted
Shandong Provincial Hospital
Jinan, Shandong 250098
ChinaSite Not Available
Novo Nordisk Investigational Site
Linyi, Shandong 276016
ChinaSite Not Available
Novo Nordisk Investigational Site
Qingdao, Shandong 266043
ChinaActive - Recruiting
Qingdao Women and Children's Hospital
Qingdao, Shandong 266043
ChinaSite Not Available
Shandong Provincial Hospital-Pediatric
Jinan 1805753, Shandong 1796328 250098
ChinaSite Not Available
Qingdao Women and Children's Hospital
Qingdao 1797929, Shandong 1796328 266043
ChinaSite Not Available
Qingdao Women and Children's Hospital-Pediatric Endocrinology&Metabolism
Qingdao 1797929, Shandong 1796328 266034
ChinaSite Not Available
Chengdu Women's and Children's central hospital
Chengdu, Sichuan 610000
ChinaSite Not Available
Novo Nordisk Investigational Site
Chengdu, Sichuan 610000
ChinaCompleted
Chengdu Women's and Children's Central Hospital
Chengdu 1815286, Sichuan 1794299 610000
ChinaSite Not Available
Novo Nordisk Investigational Site
Hangzhou, Zhejiang 310003
ChinaSite Not Available
The Children's Hospital, Zhejiang University school of medicine
Hangzhou, Zhejiang 310052
ChinaSite Not Available
Novo Nordisk Investigational Site
Jiaxing, Zhejiang 314000
ChinaCompleted
Children's Hospital, Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764 310052
ChinaSite Not Available

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