?Determining efficacy and safety of recombinant growth hormone Somatin® (AryaTinaGene) compared to Norditropin® (Novonordisk) in children with growth hormone deficiency: A non-inferiority phase III randomized parallel clinical trial

Arya Tina Gene company0 个研究点目标入组 80 人开始时间: 待定最近更新: 2022年11月21日

试验速览

暂无简介。

•Children older than 2 and younger than 10 for girls and 11 for boys.
•Short stature with height standard deviation score (HSDS)?-3SD,<brNo increase in growth hormone more than 10 or 20 mlU/L after fasting and clonidine stimulating test
•Signing the written informed consent by the gradians and assent by children older than 7

•Any history of using GH or history of using estrogen of adrenal androgens within last year.
•History of seizure, sleep apnea syndrome or other respiratory disorders.
•Concomitant use of corticosteroid
•Any chronic systemic disorders such as hypothyroidism, DM, rickets, skeletal dysplasia, pervious chromosomal abnormalities
•Sensitivity to GH
•History of chemotherapy of radiotherapy
•Children with psychosocial dwarfism or idiopathic or familial short stature
•Children with idiopathic or familial short stature
•Spinal disorders such as scoliosis, kyphosis, chiari malformation, spinabifida variations

发起方

Arya Tina Gene company