A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ… (NCT04633057) | Clinical Trial Compass
CompletedPhase 3
A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency
China168 participantsStarted 2021-01-25
Plain-language summary
A Phase III, Randomized, open-label, positive-drug parallel control, Study to Evaluate the Efficacy and Safety of TJ101 in Child subject with growth hormone deficieney.
Who can participate
Age range3 Years – 12 Years
SexALL
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Inclusion criteria
✓. Boys: 3 years ≤ boy's age ≤ 10 years；Girls: 3 years ≤ girl's age ≤ 9 years
✓. Pre-pubertal children(Tanner stage I)
✓. GHD confirmed by 2 different GH provocation tests with peak GH concentration below 10 ng/mL in screening or one month
✓. Height (HT) of at least 2.0 standard deviations (SD) below the mean height for chronological age (CA) and gender according to Table of standard deviation unit values of age and height of Chinese children aged 3-12 years , (HT SDS ≤ -2.0)
✓. Height velocity≤5.0cm/years (Including height records before at least three months)；
✓. IGF-1 SDS≤-1.0
✓. Bone age (BA) is no more than two chronological age
✓. Body mass Index (BMI) must be within ±2 SD of mean BMI for the chronological age and sex according to Table of standard deviation unit values of Age and BMI of Chinese children aged 3-12 years
Exclusion criteria
✕. beyond physiological dosage of glucocorticoid therapy
✕. Evidence of closed epiphyses
✕. Any other chronic condition that can cause short stature and cannot be treated with hormone replacement therapy(Including but not limited Chronic kidney disease, malnutrition, absorption disorders, uncontrolled hypothyroidism, celiac disease, rickets and social-psychological dwarfism)
. Abnormal liver and renal function (ALT\>1.5 times the upper limit of normal range and Cr exceeding the upper limit of normal range)
✕. Presence of anti-hGH antibodies at screening
✕. Concomitant administration of other treatments that may have an effect on growth such as anabolic steroids, with the exception of ADHD(attention deficit hyperactivity disorder) drug hormone replacement therapies \[thyroxine, hydrocortisone, desmopressin (DDAVP)\]
✕. Mutations in growth hormone receptors are suspected, or any syndrome that causes insensitivity to growth hormone