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Informed consent of parent or legally acceptable representative of participant and child assent, as age-appropriate must be obtained before any trial related activities |
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The parent or legally acceptable representative of the child must sign and date the Informed consent form (according to local requirements) |
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The child must sign and date child assent form or provide oral assent (if required according to local requirements) |
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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 |
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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) |
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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 |
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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 |
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For children with at least 2 additional pituitary hormone deficiencies (other than growth hormone deficiency) only one growth hormone stimulation test is needed |
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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 |
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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 |
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No prior exposure to growth hormone therapy or IGF-I treatment |
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Bone age less than chronological age at screening |
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Body Mass Index more than 5th and less than 95th percentile, Body Mass Index-for-age growth charts according to Chinese general population standards |
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IGF-I < -1.0 SDS at screening, compared to age and gender normalized range measured at central laboratory |
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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 |
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Known or suspected hypersensitivity to trial product(s) or related products
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Previous participation in this trial. Participation is defined as randomisation
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Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical trial before randomisation
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Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
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Turner Syndrome (including mosaicisms)
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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
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Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
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Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome or skeletal dysplasias
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Family history of skeletal dysplasia
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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
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Children diagnosed with diabetes mellitus or screening values from central laboratory of
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fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or
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HbA1c more than or equal to 6.5 %
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Current inflammatory diseases requiring systemic corticosteroid treatment for longer
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than 2 consecutive weeks within the last 3 months prior to screening
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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
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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)
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Diagnosis of attention deficit hyperactivity disorder
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Prior history or presence of malignancy including intracranial tumours
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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)
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Any clinically significant abnormal laboratory screening tests, as judged by the study doctor
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Any disorder which, in the opinion of the study doctor, might jeopardise Participant's safety or compliance with the protocol
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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
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Children with hypothyroidism and/or adrenal insufficiency not on adequate and stable replacement therapy for at least 90 days prior to randomisation
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