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.

Conditions: Growth Hormone Deficiency in Children

Summary: the study compares two medicines for children with a low level of hormone to grow: somapacitan (a new medicine) given once a week and norditropin® (a medicine doctors can already prescribe) given once a day. researchers will test somapacitan to see how well it works, compared to the standard treatment with norditropin®. the participants will either get norditropin® once every day or somapacitan once every week - which treatment the participant gets is decided by chance. the participant and the study doctor will know which treatment the participant gets. the study includes a 52 week treatment period and a minimum of 30 days follow up period.


Eligibility 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.