Safety and Efficacy of CinnaGen Human Recombinant Growth Hormone in Comparison with Novo Nordisk Growth Hormone in Children with Idiopathic Growth Hormone Deficiency: A Randomized Clinical Trial

CinnaGen Pharmaceutical Company0 个研究点目标入组 30 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•age between 4 and 16 years, pre-pubertal or early puberty stage; height standard deviation score<-2 in diagnosis time; growth hormone level post stimulating test by clonidine <10 ng/ml; rule out of the other causes of growth hormone deficiency; Documented Pituitary or hypothalamic hormone deficiency or low normal serum IGF-1 at the time of diagnosis; In case of the deficiency in other pituitary hormones, the patient can only be included, if the replacement of other pituitary hormones was done
•Exclusion criteria: acute or systemic disorders such as seizure, infectious diseases, chronic pulmonary infection, AIDS, chronic liver disease; Turner syndrome, chronic kidney disease; Any active malignancy; Contraindications of the administration of growth hormone (sleep apnea syndrome); Short stature due other causes of GHD; History of diabetes in patient or his/her first-degree relatives; prednisolone usage except for replacement therapy.

发起方

CinnaGen Pharmaceutical Company